Chapters
dict | Annexes
dict |
|---|---|
{
"articles": {
"Article 1": {
"heading": "Subject matter and scope",
"text": "Article 1(6) Article 1(5) Article 1(6) \n— Article 1(6) — \n— Article 1(8) Article 1(13)"
},
"Article 10": null,
"Article 100": null,
"Article 101": null,
"Article 102": null,
"Article 103": null,
"Article 104": null,
"Article 105": null,
"Article 106": null,
"Article 107": null,
"Article 108": null,
"Article 109": null,
"Article 11": null,
"Article 110": null,
"Article 111": null,
"Article 112": null,
"Article 113": null,
"Article 114": null,
"Article 115": null,
"Article 116": null,
"Article 117": null,
"Article 118": null,
"Article 119": null,
"Article 12": null,
"Article 120": null,
"Article 121": null,
"Article 122": null,
"Article 123": null,
"Article 13": null,
"Article 14": null,
"Article 15": null,
"Article 16": null,
"Article 17": null,
"Article 18": null,
"Article 19": null,
"Article 2": {
"heading": "Definitions",
"text": "Article 2 Article 2 Article 5(1)"
},
"Article 20": null,
"Article 21": null,
"Article 22": null,
"Article 23": null,
"Article 24": null,
"Article 25": null,
"Article 26": null,
"Article 27": null,
"Article 28": null,
"Article 29": null,
"Article 3": {
"heading": "Amendment of certain definitions",
"text": "Article 3 second paragraph Article 3 second paragraph Article 1(12)"
},
"Article 30": null,
"Article 31": null,
"Article 32": null,
"Article 33": null,
"Article 35": null,
"Article 36": null,
"Article 37": null,
"Article 38": null,
"Article 39": null,
"Article 4": {
"heading": "Regulatory status of products",
"text": "Article 4(5)(b) Article 4(5) second subparagraph —"
},
"Article 40": null,
"Article 41": null,
"Article 42": null,
"Article 43": null,
"Article 44": null,
"Article 45": null,
"Article 46": null,
"Article 47": null,
"Article 48": null,
"Article 49": null,
"Article 5": null,
"Article 50": null,
"Article 51": null,
"Article 52": null,
"Article 53": null,
"Article 54": null,
"Article 55": null,
"Article 56": null,
"Article 57": null,
"Article 58": null,
"Article 59": null,
"Article 6": null,
"Article 60": null,
"Article 61": null,
"Article 62": null,
"Article 63": null,
"Article 64": null,
"Article 65": null,
"Article 66": null,
"Article 67": null,
"Article 68": null,
"Article 69": null,
"Article 7": null,
"Article 70": null,
"Article 71": null,
"Article 72": null,
"Article 73": null,
"Article 74": null,
"Article 75": null,
"Article 76": null,
"Article 77": null,
"Article 78": null,
"Article 79": null,
"Article 8": null,
"Article 80": null,
"Article 81": null,
"Article 82": null,
"Article 83": null,
"Article 84": null,
"Article 85": null,
"Article 86": null,
"Article 87": null,
"Article 88": null,
"Article 89": null,
"Article 9": null,
"Article 90": null,
"Article 91": null,
"Article 92": null,
"Article 93": null,
"Article 94": null,
"Article 95": null,
"Article 96": null,
"Article 97": null,
"Article 98": null,
"Article 99": null
},
"title": "Scope and definitions"
}
|
{
"text": "met, together with the grounds, \n— where applicable, an indication that the device contains or incor porate s a medicinal substance, including a human \nblood or plasma derivative, or tissues or cells of human origin, or of animal origin as refer red to in \nRegulation (EU) No 722/2012. \n2. The manuf acturer shall under take to keep available for the compet ent national author ities documentation that \nindicates its manuf actur ing site or sites and allows an understanding to be formed of the design, manufacture and \nperf ormance of the device, including the expected performa nce, so as to allow assessment of conf ormity with the \nrequirements of this Regulation. \n3. The manufacturer shall take all the measures necessar y to ensure that the manufact uring process produces devices \nwhic h are manuf actured in accordance with the documentation refer red to in Section 2. \n4. The statement referred to in the introduct ory part of Section 1 shall be kept for a period of at least 10 years after the \ndevice has been placed on the market. In the case of implantable devices, the period shall be at least 15 years. \nSection 8 of Annex IX shall apply . \n5. The manufacturer shall review and document exper ience gained in the post-production phase, including from PMCF \nas refer red to in Part B of Annex XIV, and implement appropr iate means to apply any necessar y corrective action, In \nthat context, it shall repor t in accordance with Article 87(1) to the compet ent author ities any serious incidents or \nfield safety corrective actions or both as soon as it learns of them. 5.5.2017 L 117/163 Official Jour nal of the European Union EN",
"title": "Annex I and, where applicable, indicating whic h general safety and performance requirements have not been fully"
}
|
{
"articles": {
"Article 1": null,
"Article 10": {
"heading": "General obligations of manufacturers",
"text": "Article 10 Article 15 Articles 62 to 82 \nArticle 10a(1), second senten ce of \nArticle 10a(2) and Article 10a(3) Article 14(1), second senten ce of"
},
"Article 100": null,
"Article 101": null,
"Article 102": null,
"Article 103": null,
"Article 104": null,
"Article 105": null,
"Article 106": null,
"Article 107": null,
"Article 108": null,
"Article 109": null,
"Article 11": {
"heading": "Authorised representative",
"text": "Article 11(7) Article 16(7) Articles 38(2) and 44(2)"
},
"Article 110": null,
"Article 111": null,
"Article 112": null,
"Article 113": null,
"Article 114": null,
"Article 115": null,
"Article 116": null,
"Article 117": null,
"Article 118": null,
"Article 119": null,
"Article 12": {
"heading": "Change of authorised representative",
"text": "Article 12 Article 17 Article 20"
},
"Article 120": null,
"Article 121": null,
"Article 122": null,
"Article 123": null,
"Article 13": {
"heading": "General obligations of importers",
"text": "Article 13 Article 18 Articles 94 to 97"
},
"Article 14": {
"heading": "General obligations of distributors",
"text": "Article 14 Article 19 Article 99"
},
"Article 15": {
"heading": "Person responsible for regulatory compliance",
"text": "Article 15 Article 20 Article 109 \nArticle 15a Article 20a Article 102"
},
"Article 16": {
"heading": "Cases in which obligations of manufacturers apply to importers, distributors or other persons",
"text": "Article 16 Article 22 —"
},
"Article 17": {
"heading": "Single-use devices and their reprocessing",
"text": "Article 17 Article 23 — \n— Article 21 — 5.5.2017 L 117/175 Official Jour nal of the European Union EN"
},
"Article 18": {
"heading": "Implant card and information to be supplied to the patient with an implanted device",
"text": "Article 18 \nImplant card and information to be supplied to the patient with an implanted device \n1. The manufacturer of an imp lantable device shall provide together with the device the following: \n(a) information allowing the identification of the device, including the device name, serial number , lot number , the UDI, \nthe device model, as well as the name, address and the website of the manufacturer; \n(b) any warnings, precautions or measures to be take n by the patient or a healthcare professional with regard to \nreciprocal interference with reasonably foreseeable exte rnal influences, medical examinations or environmental \nconditions; \n(c) any information about the expect ed lifetime of the device and any necessar y follow-up; \n(d) any other information to ensure safe use of the device by the patient, including the information in point (u) of \nSection 23.4 of Annex I. 5.5.2017 L 117/31 Official Jour nal of the European Union EN \n The information referred to in the first subparagraph shall be provided, for the purpose of making it available to the \nparticular patient who has been implant ed with the device, by any means that allow rapid access to that information \nand shall be stated in the languag e(s) determined by the concer ned Member State . The information shall be written in \na way that is readily underst ood by a lay person and shall be updated where appropr iate. Update s of the information \nshall be made available to the patient via the website mentioned in point (a) of the first subparagraph. \nIn addition, the manuf acturer shall provide the information refer red to in point (a) of the first subparagraph on an \nimplant card delivered with the device. \n2. Member States shall require health institutions to make the information refer red to in paragraph 1 available, by \nany means that allow rapid access to that information, to any patients who have been implanted with the device, \ntogether with the implant card, whic h shall bear their identity . \n3. The following implants shall be exem pted from the oblig ations laid down in this Article: sutures, staples, dental \nfillings, dental braces, tooth crowns, screws, wedges, plates , wires, pins, clips and connectors. The Commission is \nempo wered to adopt delegat ed acts in accordance with Article 115 to amend this list by adding other types of implants \nto it or by remo ving implants therefrom."
},
"Article 19": {
"heading": "EU declaration of conformity",
"text": "Article 19 \nEU declaration of confo rmity \n1. The EU declaration of conf ormity shall state that the requirements specif ied in this Regulation have been fulfilled \nin relation to the device that is covered. The manufa cturer shall continuously updat e the EU declaration of conf ormity . \nThe EU declaration of conf ormity shall, as a minimum, contain the information set out in Annex IV and shall be \ntranslate d into an official Union language or languag es required by the Member State (s) in whic h the device is made \navailable. \n2. Where, concer ning aspects not covered by this Regulation, devices are subject to other Union legislation which \nalso requires an EU declaration of conf ormity by the manuf acturer that fulfilment of the requirements of that legislation \nhas been demonstrated , a sing le EU declaration of conf ormity shall be drawn up in respect of all Union acts applicable \nto the device. The declaration shall contain all the information required for identification of the Union legislation to \nwhic h the declaration relat es. \n3. By drawing up the EU declaration of conf ormity , the manufacturer shall assume responsibility for compliance with \nthe requirements of this Regulation and all other Union legislation applicable to the device. \n4. The Commission is empo wered to adopt delegat ed acts in accordance with Article 115 amending the minimum \nconte nt of the EU declaration of conf ormity set out in Annex IV in the light of technical progress."
},
"Article 2": null,
"Article 20": {
"heading": "CE marking of conformity",
"text": "Article 20 \nCE marking of conformity \n1. Devices, other than custom-made or inve stigational devices, considered to be in conf ormity with the requirements \nof this Regulation shall bear the CE marking of conf ormity , as present ed in Annex V. \n2. The CE marking shall be subject to the general principles set out in Article 30 of Regulation (EC) No 765/2008. \n3. The CE marking shall be affixed visibly , legibly and indelibly to the device or its sterile packag ing. Where such \naffixing is not possible or not warranted on account of the nature of the device, the CE marking shall be affixed to the \npackag ing. The CE marking shall also appear in any instr uctions for use and on any sales packaging. \n4. The CE marking shall be affixed before the device is placed on the mark et. It may be followed by a pictogram or \nany other mark indicating a special risk or use. \n5. Where applicable, the CE marking shall be followed by the identif ication number of the notified body responsible \nfor the conf ormity assessment procedures set out in Article 52. The identification number shall also be indicate d in any \npromotional mater ial which mentions that a device fulfils the requirements for CE marking. \n6. Where devices are subject to other Union legislation whic h also provides for the affixing of the CE marking, the \nCE marking shall indicate that the devices also fulfil the requirements of that other legislation. 5.5.2017 L 117/32 Official Jour nal of the European Union EN"
},
"Article 21": {
"heading": "Devices for special purposes",
"text": "Article 21 \nDevices for special pur poses \n1. Member States shall not creat e obstacles to: \n(a) inve stigational devices being supplied to an inve stigat or for the purpose of a clinical investig ation if they meet the \nconditions laid down in Articles 62 to 80 and Article 82, in the implementing acts adop ted pursuant to Article 81 \nand in Annex XV; \n(b) custom-mad e devices being made available on the mark et if Article 52(8) and Annex XIII have been compl ied with. \nThe devices refer red to in the first subparagraph shall not bear the CE marking, with the exce ption of the devices \nreferred to in Article 74. \n2. Cust om-made devices shall be accompan ied by the state ment referred to in Section 1 of Annex XIII, whic h shall be \nmade available to the particular patient or user identif ied by name, an acron ym or a numer ical code. \nMember States may require that the manuf acturer of a custom-made device submit to the compet ent author ity a list of \nsuch devices which have been made available in their territory . \n3. At trade fairs, exhibitions, demonstrations or similar events, Member States shall not creat e obstacles to the \nshowing of devices which do not compl y with this Regulation, provided a visible sign clearly indicates that such devices \nare intended for presentation or demonstration purposes only and cannot be made available until they have been \nbrought into compl iance with this Regulation."
},
"Article 22": {
"heading": "Systems and procedure packs",
"text": "Article 22 \nSystems and procedure packs \n1. Natural or legal persons shall draw up a statement if they combine devices bear ing a CE marking with the \nfollowing other devices or products, in a manner that is compati ble with the intended purpose of the devices or other \nproducts and within the limits of use specifi ed by their manuf acturers, in order to place them on the mark et as a system \nor procedure pack: \n(a) other devices bear ing the CE marking; \n(b) in vitro diagnostic medical devices bear ing the CE marking in conf ormity with Regulation (EU) 2017/746; \n(c) other products whic h are in conf ormity with legislation that applies to those products only where they are used \nwithin a medical procedure or their presence in the syste m or procedure pack is other wise justif ied. \n2. In the statement made pursuant to paragraph 1, the natural or legal person concer ned shall declare that: \n(a) they verified the mutual compati bility of the devices and, if applicable other products, in accordance with the manu \nfacturers' instr uctions and have carried out their activities in accordance with those instr uctions; \n(b) they packag ed the system or procedure pack and supplied relevant information to users incor porating the \ninformation to be supplied by the manuf acturers of the devices or other products whic h have been put together; \n(c) the activity of combining devices and, if applicable, other products as a system or procedure pack was subject to \nappropr iate methods of internal monitori ng, verification and validation. \n3. Any natural or legal person who steri lises systems or procedure packs refer red to in paragraph 1 for the purpose \nof placing them on the market shall, at their choice, apply one of the procedures set out in Annex IX or the procedure \nset out in Part A of Annex XI. The application of those procedures and the involvement of the notified body shall be \nlimited to the aspects of the procedure relating to ensur ing sterilit y until the sterile packa ging is opened or damage d. \nThe natural or legal person shall draw up a state ment declar ing that sterilisation has been carried out in accordance with \nthe manufact urer's instr uctions. \n4. Where the system or procedure pack incor porate s devices which do not bear the CE marking or where the chosen \ncombination of devices is not compati ble in view of their original intended purpose, or where the sterilisation has not \nbeen carried out in accordance with the manufacturer's instr uctions, the system or procedure pack shall be treated as \na device in its own right and shall be subject to the relevant conf ormity assessment procedure pursuant to Article 52. \nThe natural or legal person shall assume the oblig ations incumbent on manuf acturers. 5.5.2017 L 117/33 Official Jour nal of the European Union EN \n 5. The system s or procedure packs referred to in paragraph 1 of this Article shall not themselves bear an additional \nCE marking but they shall bear the name, registered trade name or registere d trade mark of the person refer red to in \nparagraphs 1 and 3 of this Article as well as the address at whic h that person can be contact ed, so that the person's \nlocation can be established. Systems or procedure packs shall be accompanied by the information referred to in \nSection 23 of Annex I. The statement refer red to in paragraph 2 of this Article shall be kept at the disposal of the \ncompet ent author ities, after the system or procedure pack has been put together , for the period that is applicable under"
},
"Article 23": {
"heading": "Parts and components",
"text": "Article 23 \nParts and components \n1. Any natural or lega l person who mak es available on the mark et an item specifically intende d to replace an \nidentical or similar integral part or compo nent of a device that is defective or worn in order to maintain or restore the \nfunction of the device without changing its performa nce or safety charact eristics or its intended purpose, shall ensure \nthat the item does not adversely affect the safety and performa nce of the device. Suppor ting evidence shall be kept \navailable for the compet ent author ities of the Member State s. \n2. An item that is intended specifi cally to replace a part or component of a device and that signif icantly chang es the \nperforma nce or safety charact eristics or the intended purpose of the device shall be considered to be a device and shall \nmeet the requirements laid down in this Regulation."
},
"Article 24": {
"heading": "Free movement",
"text": "Article 24 \nFree movement \nExcept where other wise provided for in this Regulation, Member States shall not refuse, prohibit or restr ict the making \navailable on the market or putting into service within their territory of devices whic h compl y with the requirements of \nthis Regulation. \nCHAPTER III \nIDENTIFIC ATION AND TRA CEABILIT Y OF DEVICES, REGISTRA TION OF DEVICES AND OF ECO NOMIC \nOPERA TORS, SUMMAR Y OF SAFE TY AND CLINIC AL PERFORM ANCE, EUR OPEAN DATABASE ON \nMEDIC AL DEVICES"
},
"Article 25": null,
"Article 26": null,
"Article 27": null,
"Article 28": null,
"Article 29": null,
"Article 3": null,
"Article 30": null,
"Article 31": null,
"Article 32": null,
"Article 33": null,
"Article 35": null,
"Article 36": null,
"Article 37": null,
"Article 38": null,
"Article 39": null,
"Article 4": null,
"Article 40": null,
"Article 41": null,
"Article 42": null,
"Article 43": null,
"Article 44": null,
"Article 45": null,
"Article 46": null,
"Article 47": null,
"Article 48": null,
"Article 49": null,
"Article 5": {
"heading": "Placing on the market and putting into service",
"text": "Article 5(2) Article 5(2) Article 8(2)"
},
"Article 50": null,
"Article 51": null,
"Article 52": null,
"Article 53": null,
"Article 54": null,
"Article 55": null,
"Article 56": null,
"Article 57": null,
"Article 58": null,
"Article 59": null,
"Article 6": {
"heading": "Distance sales",
"text": "Article 6(2) Article 7(1) Article 114"
},
"Article 60": null,
"Article 61": null,
"Article 62": null,
"Article 63": null,
"Article 64": null,
"Article 65": null,
"Article 66": null,
"Article 67": null,
"Article 68": null,
"Article 69": null,
"Article 7": {
"heading": "Claims",
"text": "Article 7 Article 8 Articles 94 to 97 \n— Article 9 Article 51"
},
"Article 70": null,
"Article 71": null,
"Article 72": null,
"Article 73": null,
"Article 74": null,
"Article 75": null,
"Article 76": null,
"Article 77": null,
"Article 78": null,
"Article 79": null,
"Article 8": {
"heading": "Use of harmonised standards",
"text": "Article 8(4) Article 10(4) Article 91"
},
"Article 80": null,
"Article 81": null,
"Article 82": null,
"Article 83": null,
"Article 84": null,
"Article 85": null,
"Article 86": null,
"Article 87": null,
"Article 88": null,
"Article 89": null,
"Article 9": {
"heading": "Common specifications",
"text": "Article 9(10) Article 11(14) Article 4(5) and Article 122 \nthird paragraph \n— Article 12 Article 22 \n— Article 12a Article 17 \nArticle 9a(1) first indent Article 13(1)(c) — \nArticle 9a(1) second indent Article 13(1)(d) Article 4(1) \n— Article 13(1)(a) Article 51(3)(a) and Article 51(6) \n— Article 13(1)(b) Article 51(3)(b) and Article 51(6)"
},
"Article 90": null,
"Article 91": null,
"Article 92": null,
"Article 93": null,
"Article 94": null,
"Article 95": null,
"Article 96": null,
"Article 97": null,
"Article 98": null,
"Article 99": null
},
"title": "Placing on the market, making available and putting into service; obligations of economic operators"
}
|
{
"text": "TECHNIC AL DOCUMENT ATION \nThe technical documentation and, if applicable, the summar y thereof to be drawn up by the manuf acturer shall be \npresent ed in a clear , organised, readily searc hable and unambiguous manner and shall include in particular the elements \nlisted in this Annex. \n1. DEVICE DESCRIPTION AND SPECIFIC ATION, INCLUDING VARIANTS AND ACCESSORIES \n1.1. Device descr iption and specification \n(a) product or trade name and a general descr iption of the device including its intended purpose and intended \nusers; \n(b) the Basic UDI-DI as referred to in Part C of Annex VI assigned by the manufacturer to the device in question, \nas soon as identif ication of this device becomes based on a UDI system, or other wise a clear identification by \nmeans of product code, catalogue number or other unambiguous reference allowing traceability ; \n(c) the intended patient population and medical conditions to be diagnosed, treated and/or monit ored and other \nconsiderations such as patient selection criteria, indications, contra-indications, warnings; \n(d) principles of operation of the device and its mode of action, scientifi cally demonstrated if necessar y; \n(e) the rationale for the qualifi cation of the product as a device; \n(f) the risk class of the device and the justif ication for the classificat ion rule(s) applied in accordance with",
"title": "ANNEX II"
}
|
{
"articles": {
"Article 1": null,
"Article 10": null,
"Article 100": null,
"Article 101": null,
"Article 102": null,
"Article 103": null,
"Article 104": null,
"Article 105": null,
"Article 106": null,
"Article 107": null,
"Article 108": null,
"Article 109": null,
"Article 11": null,
"Article 110": null,
"Article 111": null,
"Article 112": null,
"Article 113": null,
"Article 114": null,
"Article 115": null,
"Article 116": null,
"Article 117": null,
"Article 118": null,
"Article 119": null,
"Article 12": null,
"Article 120": null,
"Article 121": null,
"Article 122": null,
"Article 123": null,
"Article 13": null,
"Article 14": null,
"Article 15": null,
"Article 16": null,
"Article 17": null,
"Article 18": null,
"Article 19": null,
"Article 2": null,
"Article 20": null,
"Article 21": null,
"Article 22": null,
"Article 23": null,
"Article 24": null,
"Article 25": {
"heading": "Identification within the supply chain",
"text": "Article 25 \nIdentif ication within the supply chain \n1. Distr ibutors and importers shall co-operate with manufacturers or author ised representatives to achi eve an \nappropr iate level of traceability of devices. \n2. Economic operators shall be able to identify the following to the compet ent author ity, for the period refer red to in"
},
"Article 26": {
"heading": "Medical devices nomenclature",
"text": "Article 26 \nMedical devices nomenclature \nTo facilitate the functioning of the European database on medical devices (‘Eudamed’) as referred to in Article 33, the \nCommission shall ensure that an intern ationally recognised medical devices nomenclature is available free of charge to \nmanufa cturers and other natural or legal persons required by this Regulation to use that nomenclature. The Commission \nshall also endeav our to ensure that that nomenclature is available to other stake holders free of charge, where reasonably \npracticable. 5.5.2017 L 117/34 Official Jour nal of the European Union EN"
},
"Article 27": {
"heading": "Unique Device Identification [UDI] system",
"text": "Article 27 \nUnique Device Identif ication system \n1. The Unique Device Identification system (‘UDI system ’) descr ibed in Part C of Annex VI shall allow the identifi \ncation and facilitat e the traceability of devices, other than custom-made and inve stigational devices, and shall consist of \nthe following: \n(a) production of a UDI that compris es the following: \n(i) a UDI device identifier (‘UDI-DI’) specific to a manuf acturer and a device, providing access to the information \nlaid down in Part B of Annex VI; \n(ii) a UDI production identif ier (‘UDI-PI’) that identif ies the unit of device production and if applicable the packa ged \ndevices, as specifi ed in Part C of Annex VI; \n(b) placing of the UDI on the label of the device or on its packaging; \n(c) storag e of the UDI by economic operat ors, health institutions and healthcare profess ionals, in accordance with the \nconditions laid down in paragraphs 8 and 9 of this Article respectively ; \n(d) establishment of an electronic system for Unique Device Identif ication (‘UDI database’) in accordance with"
},
"Article 28": {
"heading": "UDI database",
"text": "Article 28 \nUDI database \n1. The Commission, after consulting the MDCG shall set up and manag e a UDI database to validate, collate, process \nand mak e available to the public the information mentioned in Part B of Annex VI. \n2. When designing the UDI database, the Commission shall take into account the general principles set out in \nSection 5 of Part C of Annex VI. The UDI database shall be designed in particular such that no UDI-PIs and no \ncommercially conf idential product information can be included therein. \n3. The core data elements to be provided to the UDI database, refer red to in Part B of Annex VI, shall be accessible to \nthe public free of charge. \n4. The technical design of the UDI database shall ensure maximum accessibility to information stored therein, \nincluding multi-user access and automatic uploads and downloads of that information. The Commission shall provide \nfor technical and administrative suppor t to manufacturers and other users of the UDI database. 5.5.2017 L 117/36 Official Jour nal of the European Union EN"
},
"Article 29": {
"heading": "Registration of devices",
"text": "Article 29 \nRegistration of devices \n1. Before placing a device, other than a custom-ma de device, on the market, the manufa cturer shall, in accordance \nwith the rules of the issuing entity referred to in Article 27(2), assign a Basic UDI-DI as defined in Part C of Annex VI to \nthe device and shall provide it to the UDI database together with the other core data elements refer red to in Part B of \nAnnex VI related to that device. \n2. Before placing on the mark et a system or procedure pack pursuant to Article 22(1) and (3), that is not a custom- \nmade device, the natural or legal person responsible shall assign to the system or procedure pack, in compliance with \nthe rules of the issuing entity , a Basic UDI-DI and shall provide it to the UDI database together with the other core data \nelements refer red to in Part B of Annex VI relat ed to that syste m or procedure pack. \n3. For devices that are the subject of a conf ormity assessment as refer red to in Article 52(3) and in the second and \nthird subparagraphs of Article 52(4), the assignment of a Basic UDI-DI refer red to in paragraph 1 of this Article shall be \ndone before the manufacturer applies to a notified body for that assessment. \nFor the devices referred to in the first subparagraph, the notified body shall include a reference to the Basic UDI-DI on \nthe certificate issued in accordance with point (a) of Section 4 of Chapt er I of Annex XII and conf irm in Eudamed that \nthe information refer red to in Section 2.2 of Part A of Annex VI is correct. After the issuing of the relevant certificate \nand before placing the device on the market, the manuf acturer shall provide the Basic UDI-DI to the UDI database \ntogether with the other core data elements referred to in Part B of Annex VI relat ed to that device. \n4. Before placing a device on the market, other than a custom-mad e device, the manufa cturer shall enter or if, already \nprovided, verify in Eudamed the information referred to in Section 2 of Part A of Annex VI, with the excep tion of \nSection 2.2 thereof, and shall thereaf ter keep the information updated."
},
"Article 3": null,
"Article 30": {
"heading": "Electronic system for registration of economic operators",
"text": "Article 30 \nElectronic system for registrati on of economic operat ors \n1. The Commission, after consulting the MDCG, shall set up and manage an electronic system to creat e the sing le \nregistration number referred to in Article 31(2) and to collat e and process information that is necessar y and propor \ntionate to identify the manufacturer and, where applicable, the author ised representative and the importer. The details \nregar ding the information to be provided to that electronic syste m by the economic operat ors are laid down in Section 1 \nof Part A of Annex VI. \n2. Member States may maintain or introduce national provisions on registration of distr ibutors of devices whic h have \nbeen made available on their territory. \n3. Within two weeks of placing a device, other than a custom-made device, on the mark et, impor ters shall verify that \nthe manufacturer or author ised representative has provided to the electronic system the information referred to in \nparagraph 1. \nWhere applicable, impor ters shall inform the relevant author ised representative or manufacturer if the information \nreferred to in paragraph 1 is not included or is incor rect. Impor ters shall add their details to the relevant entr y/entr ies."
},
"Article 31": {
"heading": "Registration of manufacturers, authorised representatives and importers",
"text": "Article 31 \nRegis tration of manufacturers, author ised representativ es and impor ters \n1. Before placing a device, other than a custom-mad e device, on the market, manufa cturers, author ised representatives \nand importers shall, in order to register , submit to the electronic system refer red to in Article 30 the information \nreferred to in Section 1 of Part A of Annex VI, provided that they have not already register ed in accordance with this \nArticle. In cases where the conf ormity assessment procedure requires the involvement of a notifi ed body pursuant to"
},
"Article 32": {
"heading": "Summary of safety and clinical performance",
"text": "Article 32, the assessment repor t by the notified body , the instr uctions for use refer red to in Section 23.4 of Annex I, \nand, where applicable, the scientific opinion of the exper t panels refer red to in Section 5.1 of Annex IX or Section 6 of \nAnnex X, as applicable. In the case of diverg ent views between the notified body and the exper t panels, a full justifi \ncation shall also be included. \n2. A compet ent author ity and, where applicable, the Commission may, based on reasonable concer ns apply further \nprocedures in accordance with Article 44, 45, 46, 47 or 94 and, where deemed necessar y, take appropr iate measures in \naccordance with Articles 95 and 97. \n3. The MDCG and, where applicable, the Commission, may, based on reasonable concer ns, request scientific advice \nfrom the exper t panels in relation to the safety and performa nce of any device."
},
"Article 33": {
"heading": "European database on medical devices",
"text": "Article 33 \nEuropean database on medical devices \n1. The Commission, after consulting the MDCG, shall set up, maintain and manage the European database on \nmedical devices (‘Eudamed’) for the following purposes: \n(a) to enable the public to be adequat ely informed about devices placed on the mark et, the corresponding certificates \nissued by notified bodies and about the relevant economic operators; 5.5.2017 L 117/38 Official Jour nal of the European Union EN \n (b) to enable unique identification of devices within the internal market and to facilitate their traceability ; \n(c) to enable the public to be adequately informed about clinical investigat ions and to enable sponsors of clinical inve sti\ngations to compl y with obligations under Articles 62 to 80, Article 82, and any acts adopt ed pursuant to Article 81; \n(d) to enable manuf acturers to compl y with the information oblig ations laid down in Articles 87 to 90 or in any acts \nadopt ed pursuant to Article 91; \n(e) to enable the compet ent author ities of the Member State s and the Commission to carry out their tasks relating to \nthis Regulation on a well-inf ormed basis and to enhance the cooperation between them. \n2. Eudamed shall include the following electronic systems: \n(a) the electronic system for registration of devices refer red to in Article 29(4); \n(b) the UDI-database referred to in Article 28; \n(c) the electronic system on registration of economic operat ors referred to in Article 30; \n(d) the electronic system on notified bodies and on certificates refer red to in Article 57; \n(e) the electronic system on clinical investig ations referred to in Article 73; \n(f) the electronic system on vigilance and post-market surveillance refer red to in Article 92; \n(g) the electronic system on mark et surveillance refer red to in Article 100. \n3. When designing Eudamed the Commission shall give due consideration to compati bility with national databases \nand national web-int erfaces to allow for import and expor t of data. \n4. The data shall be entered into Eudamed by the Member State s, notified bodies, economic operat ors and sponsors \nas specifi ed in the provisions on the electronic systems refer red to in paragraph 2. The Commission shall provide for \ntechnical and administrative suppor t to users of Eudamed. \n5. All the information collated and processed by Eudamed shall be accessible to the Member State s and to the \nCommission. The information shall be accessible to notifi ed bodies, economic operators, sponsors and the public to the \nextent specified in the provisions on the electronic systems refer red to in paragraph 2. \nThe Commission shall ensure that public parts of Eudamed are presented in a user -friendly and easily-searchab le format. \n6. Eudamed shall contain personal data only insof ar as necessar y for the electronic syste ms referred to in paragraph 2 \nof this Article to collate and process information in accordance with this Regulation. Personal data shall be kept in \na form which permits identif ication of data subjects for periods no long er than those refer red to in Article 10(8). \n7. The Commission and the Member State s shall ensure that data subjects may effectively exer cise their rights to \ninformation, of access, to rectificatio n and to object in accordance with Regulation (EC) No 45/2001 and \nDirective 95/46/EC, respectively . They shall also ensure that data subjects may effectively exercise the right of access to \ndata relating to them, and the right to have inaccurat e or incomplet e data corrected and erased. Within their respective \nresponsibilities, the Commission and the Member States shall ensure that inaccurate and unlawfully processed data are \ndelet ed, in accordance with the applicable legislation. Corrections and deletions shall be carried out as soon as possible, \nbut no later than 60 days after a request is made by a data subject. \n8. The Commission shall, by means of imp lementing acts, lay down the detailed arrang ements necessar y for the \nsetting up and maint enance of Eudamed. Those implementing acts shall be adopt ed in accordance with the examination \nprocedure refer red to in Article 114(3). When adop ting those implementing acts, the Commission shall ensure that, as \nfar as possible, the system is developed in such a way as to avoid having to enter the same information twice within the \nsame module or in diffe rent modules of the system . \n9. In relation to its responsibilities under this Article and the processing of personal data involved therein, the \nCommission shall be considered to be the controller of Eudamed and its electronic systems. 5.5.2017 L 117/39 Official Jour nal of the European Union EN"
},
"Article 35": null,
"Article 36": null,
"Article 37": null,
"Article 38": null,
"Article 39": null,
"Article 4": null,
"Article 40": null,
"Article 41": null,
"Article 42": null,
"Article 43": null,
"Article 44": null,
"Article 45": null,
"Article 46": null,
"Article 47": null,
"Article 48": null,
"Article 49": null,
"Article 5": null,
"Article 50": null,
"Article 51": null,
"Article 52": null,
"Article 53": null,
"Article 54": null,
"Article 55": null,
"Article 56": null,
"Article 57": null,
"Article 58": null,
"Article 59": null,
"Article 6": null,
"Article 60": null,
"Article 61": null,
"Article 62": null,
"Article 63": null,
"Article 64": null,
"Article 65": null,
"Article 66": null,
"Article 67": null,
"Article 68": null,
"Article 69": null,
"Article 7": null,
"Article 70": null,
"Article 71": null,
"Article 72": null,
"Article 73": null,
"Article 74": null,
"Article 75": null,
"Article 76": null,
"Article 77": null,
"Article 78": null,
"Article 79": null,
"Article 8": null,
"Article 80": null,
"Article 81": null,
"Article 82": null,
"Article 83": null,
"Article 84": null,
"Article 85": null,
"Article 86": null,
"Article 87": null,
"Article 88": null,
"Article 89": null,
"Article 9": null,
"Article 90": null,
"Article 91": null,
"Article 92": null,
"Article 93": null,
"Article 94": null,
"Article 95": null,
"Article 96": null,
"Article 97": null,
"Article 98": null,
"Article 99": null
},
"title": "Identification and traceability of devices, registration of devices and of economic operators"
}
|
{
"text": "TEC HNIC AL DOCUMENT ATION ON POST -MARKET SUR VEILL ANCE \nThe technical documentation on post-market surveillance to be drawn up by the manuf acturer in accordance with \nArticles 83 to 86 shall be present ed in a clear , organised, readily searc hable and unambiguous manner and shall include \nin particular the elements descr ibed in this Annex. \n1.1. The post-market surveillance plan drawn up in accordance with Article 84. \nThe manufacturer shall prove in a post-market surveillance plan that it compl ies with the obligation referred to \nin Article 83. \n(a) The post-market surveillance plan shall address the collection and utilization of available information, in \nparticular: \n— information concer ning serious incidents, including information from PSURs, and field safety corrective \nactions; \n— records refer ring to non-ser ious incidents and data on any undesirable side-eff ects; \n— information from trend repor ting; \n— relevant specialist or technical literature, databases and/or register s; \n— information, including feedbacks and complaints, provided by users, distr ibut ors and impor ters; and \n— publicly available information about similar medical devices. \n(b) The post-market surveillance plan shall cover at least : \n— a proactive and syste matic process to collect any information refer red to in point (a). The process shall \nallow a correct charact erisation of the perf ormance of the devices and shall also allow a compari son to \nbe made between the device and similar products available on the market ; \n— effective and appropr iate methods and processes to assess the collected data; \n— suitable indicators and threshold values that shall be used in the continuous reassessment of the benefit- \nrisk analysis and of the risk managemen t as referred to in Section 3 of Annex I; \n— effective and appropr iate methods and tools to investig ate compl aints and analyse mark et-related \nexper ience collect ed in the field; \n— methods and protocols to manage the events subject to the trend repor t as provided for in Article 88, \nincluding the methods and prot ocols to be used to establish any statistically signif icant increase in the \nfrequency or sever ity of incidents as well as the obser vation period; \n— methods and protocols to communicate effectively with compet ent author ities, notifi ed bodies, economic \noperat ors and users; \n— reference to procedures to fulfil the manuf acturers oblig ations laid down in Articles 83, 84 and 86; \n— system atic procedures to identify and initiate appropr iate measures including corrective actions; \n— effective tools to trace and identify devices for which corrective actions might be necessar y; and \n— a PMCF plan as refer red to in Part B of Annex XIV, or a justif ication as to why a PMCF is not applicable. \n1.2. The PSUR refer red to in Article 86 and the post-market surveillance repor t refer red to in Article 85. 5.5.2017 L 117/112 Official Jour nal of the European Union EN",
"title": "ANNEX III"
}
|
{
"articles": {
"Article 1": null,
"Article 10": null,
"Article 100": null,
"Article 101": null,
"Article 102": null,
"Article 103": null,
"Article 104": null,
"Article 105": null,
"Article 106": null,
"Article 107": null,
"Article 108": null,
"Article 109": null,
"Article 11": null,
"Article 110": null,
"Article 111": null,
"Article 112": null,
"Article 113": null,
"Article 114": null,
"Article 115": null,
"Article 116": null,
"Article 117": null,
"Article 118": null,
"Article 119": null,
"Article 12": null,
"Article 120": null,
"Article 121": null,
"Article 122": null,
"Article 123": null,
"Article 13": null,
"Article 14": null,
"Article 15": null,
"Article 16": null,
"Article 17": null,
"Article 18": null,
"Article 19": null,
"Article 2": null,
"Article 20": null,
"Article 21": null,
"Article 22": null,
"Article 23": null,
"Article 24": null,
"Article 25": null,
"Article 26": null,
"Article 27": null,
"Article 28": null,
"Article 29": null,
"Article 3": null,
"Article 30": null,
"Article 31": null,
"Article 32": null,
"Article 33": null,
"Article 35": {
"heading": "Authorities responsible for notified bodies",
"text": "Article 35 \nAuthor ities responsible for notif ied bodies \n1. Any Member State that intends to designat e a conf ormity assessment body as a notifi ed body , or has designat ed \na notified body , to carry out conf ormity assessment activities under this Regulation shall appoint an author ity (‘author ity \nresponsible for notified bodies’), which may consist of separate constituent entities under national law and shall be \nresponsible for setting up and carrying out the necessar y procedures for the assessment, designation and notificati on of \nconf ormity assessment bodies and for the monitori ng of notifi ed bodies, including subcontractors and subsidiar ies of \nthose bodies. \n2. The author ity responsible for notified bodies shall be established, organised and operat ed so as to safeg uard the \nobjectivity and impartiality of its activities and to avoid any conf licts of interests with conf ormity assessment bodies. \n3. The author ity responsible for notified bodies shall be organised in a manner such that each decision relating to \ndesignation or notificati on is taken by personnel diffe rent from those who carried out the assessment. \n4. The author ity responsible for notified bodies shall not perform any activities that notified bodies perform on \na commercial or compe titive basis. \n5. The author ity responsible for notified bodies shall safeg uard the confidential aspects of the information it obtains. \nHowever , it shall exchang e information on notifi ed bodies with other Member State s, the Commission and, when \nrequired, with other regulatory author ities. \n6. The author ity responsible for notified bodies shall have a sufficient number of compet ent personnel permanently \navailable for the proper performa nce of its tasks. \nWhere the author ity responsible for notifi ed bodies is a diffe rent author ity from the national compet ent author ity for \nmedical devices, it shall ensure that the national author ity responsible for medical devices is consulted on relevant \nmatt ers. \n7. Member State s shall make publicly available general information on their measures governing the assessment, \ndesignation and notificati on of conf ormity assessment bodies and for the monitoring of notifi ed bodies, and on chang es \nwhic h have a signif icant impact on such tasks. \n8. The author ity responsible for notified bodies shall participat e in the peer -review activities provided for in"
},
"Article 36": {
"heading": "Requirements relating to notified bodies",
"text": "Article 36 \nRequirements relating to notif ied bodies \n1. Notified bodies shall fulfil the tasks for which they are designat ed in accordance with this Regulation. They shall \nsatisfy the organisational and general requirements and the quality management, resource and process requirements that \nare necessar y to fulfil those tasks. In particular , notifi ed bodies shall compl y with Annex VII. \nIn order to meet the requirements refer red to in the first subparagraph, notifi ed bodies shall have permanent availability \nof suffi cient administrative, technical and scientific personnel in accordance with Section 3.1.1 of Annex VII and \npersonnel with relevant clinical exper tise in accordance with Section 3.2.4 of Annex VII, where possible employed by \nthe notified body itself. \nThe personnel refer red to in Sections 3.2.3 and 3.2.7 of Annex VII shall be emplo yed by the notifi ed body itself and \nshall not be external exper ts or subcontractors. \n2. Notified bodies shall mak e available and submit upon request all relevant documentation, including the manufac \nturer's documentation, to the author ity responsible for notified bodies to allow it to conduct its assessment, designation, \nnotificati on, monit oring and surveillance activities and to facilitate the assessment outlined in this Chapt er. \n3. In order to ensure the unif orm application of the requirements set out in Annex VII, the Commission may adopt \nimplementing acts, to the extent necessar y to resolve issues of diverge nt interpretat ion and of practical application. \nThose implementing acts shall be adopt ed in accordance with the examination procedure referred to in Article 114(3)."
},
"Article 37": {
"heading": "Subsidiaries and subcontracting",
"text": "Article 37 \nSubsidiar ies and subcontracting \n1. Where a notified body subcontracts specific tasks connected with conf ormity assessment or has recourse to \na subsidiar y for specifi c tasks connected with conf ormity assessment, it shall verify that the subcontractor or the \nsubsidiar y meets the applicable requirements set out in Annex VII and shall inform the author ity responsible for notifi ed \nbodies according ly. \n2. Notified bodies shall take full responsibility for the tasks performed on their behalf by subcontract ors or \nsubsidiar ies. \n3. Notified bodies shall make publicly available a list of their subsidiar ies. \n4. Conf ormity assessment activities may be subcontracte d or carried out by a subsidiar y provided that the legal or \nnatural person that applied for conf ormity assessment has been informed according ly. \n5. Notified bodies shall keep at the disposal of the author ity responsible for notifi ed bodies all relevant documents \nconcer ning the verification of the qualifications of the subcontractor or the subsidiar y and the work carried out by them \nunder this Regulation."
},
"Article 38": {
"heading": "Application by conformity assessment bodies for designation",
"text": "Article 38 is compl ete and shall request the applicant to provide any missing information. Once the application is \ncompl ete that author ity shall send it to the Commission. \nThe author ity responsible for notified bodies shall review the application and suppor ting documentation in accordance \nwith its own procedures and shall draw up a preliminar y assessment repor t. \n2. The author ity responsible for notifi ed bodies shall submit the preliminar y assessment repor t to the Commission \nwhic h shall immediat ely transmit it to the MDCG. \n3. Within 14 days of the submission refer red to in paragraph 2 of this Article, the Commission, in conjunction with \nthe MDCG, shall appoint a joint assessment team made up of three exper ts, unless the specific circumstances require \na differ ent number of exper ts, chosen from the list referred to in Article 40(2). One of the exper ts shall be a representa \ntive of the Commission who shall coordinate the activities of the joint assessment team. The other two exper ts shall \ncome from Member States other than the one in which the applicant conf ormity assessment body is established. \nThe joint assessment team shall be compris ed of exper ts who are compet ent to assess the conf ormity assessment \nactivities and the types of devices which are the subject of the application or, in particular when the assessment \nprocedure is initiated in accordance with Article 47(3), to ensure that the specifi c concer n can be appropr iately assessed. \n4. Within 90 days of its appointment, the joint assessment team shall review the documentation submitted with the \napplication in accordance with Article 38. The joint assessment team may provide feedback to, or require clarification \nfrom, the author ity responsible for notified bodies on the application and on the planned on-site assessment. \nThe author ity responsible for notified bodies together with the joint assessment team shall plan and conduct an on-site \nassessment of the applicant conf ormity assessment body and, where relevant, of any subsidiar y or subcontractor , locat ed \ninside or outside the Union, to be involved in the conf ormity assessment process. \nThe on-site assessment of the applicant body shall be led by the author ity responsible for notified bodies. \n5. Findings regar ding non-com pliance of an applicant conf ormity assessment body with the requirements set out in \nAnnex VII shall be raised during the assessment process and discussed between the author ity responsible for notifi ed \nbodies and the joint assessment team with a view to reaching consensus and resolving any diverging opinions, with \nrespect to the assessment of the application. \nAt the end of the on-site assessment, the author ity responsible for notifi ed bodies shall list for the applicant conf ormity \nassessment body the non-com pliances resulting from the assessment and summar ise the assessment by the joint \nassessment team. \nWithin a specifi ed timeframe, the applicant conf ormity assessment body shall submit to the national author ity \na corrective and preventive action plan to address the non-compliances. \n6. The joint assessment team shall document any remaining diverging opinions with respect to the assessment within \n30 days of completion of the on-site assessment and send them to the author ity responsible for notifi ed bodies. \n7. The author ity responsible for notified bodies shall following receipt of a corrective and preventive action plan from \nthe applicant body assess whether non-com pliances identif ied during the assessment have been appropr iately addressed. \nThis plan shall indicate the root cause of the identif ied non-complian ces and shall include a timeframe for implemen \ntation of the actions therein. \nThe author ity responsible for notified bodies shall having conf irmed the corrective and preventive action plan forward it \nand its opinion thereon to the joint assessment team. The joint assessment team may request of the author ity \nresponsible for notifi ed bodies further clarification and modifications. 5.5.2017 L 117/42 Official Jour nal of the European Union EN \n The author ity responsible for notified bodies shall draw up its final assessment repor t whic h shall include: \n— the result of the assessment, \n— confir mation that the corrective and preventive actions have been appropr iately addressed and, where required, \nimplemented , \n— any remaining diverging opinion with the joint assessment team, and, where applicable, \n— the recommended scope of designation. \n8. The author ity responsible for notifi ed bodies shall submit its final assessment repor t and, if applicable, the draf t \ndesignation to the Commission, the MDCG and the joint assessment team. \n9. The joint assessment team shall provide a final opinion regarding the assessment repor t prepared by the author ity \nresponsible for notifi ed bodies and, if applicable, the draf t designation within 21 days of receip t of those documents to \nthe Commission, whic h shall immediat ely submit that final opinion to the MDCG. Within 42 days of receipt of the \nopinion of the joint assessment team, the MDCG shall issue a recommendation with regar d to the draf t designation, \nwhic h the author ity responsible for notifi ed bodies shall duly take into consideration for its decision on the designation \nof the notified body . \n10. The Commission may, by means of imp lementing acts, adop t measures setting out the detailed arrange ments \nspecifying procedures and repor ts for the application for designation refer red to in Article 38 and the assessment of the \napplication set out in this Article. Those imple menting acts shall be adopt ed in accordance with the examination \nprocedure refer red to in Article 114(3)."
},
"Article 39": {
"heading": "Assessment of the application",
"text": "Article 39 \nAssessment of the application \n1. The author ity responsible for notified bodies shall within 30 days chec k that the application refer red to in"
},
"Article 4": null,
"Article 40": {
"heading": "Nomination of experts for joint assessment of applications for notification",
"text": "Article 40 \nNomination of exper ts for joint assessment of applications for notif ication \n1. The Member State s and the Commission shall nominate exper ts qualified in the assessment of conf ormity \nassessment bodies in the field of medical devices to participat e in the activities refer red to in Articles 39 and 48. \n2. The Commission shall maintain a list of the exper ts nominated pursuant to paragraph 1 of this Article, together \nwith information on their specifi c field of compet ence and exper tise. That list shall be made available to Member States \ncompet ent author ities through the electronic system refer red to in Article 57."
},
"Article 41": {
"heading": "Language requirements",
"text": "Article 41 \nLanguage requirements \nAll documents required pursuant to Articles 38 and 39 shall be drawn up in a language or languag es which shall be \ndetermined by the Member State concer ned. \nMember State s, in applying the first paragraph, shall consider accepti ng and using a commonly understood language in \nthe medical field, for all or part of the documentation concer ned. \nThe Commission shall provide translations of the documentation pursuant to Articles 38 and 39, or parts thereof into \nan official Union language, such as is necessar y for that documentation to be readily underst ood by the joint assessment \nteam appointed in accordance with Article 39(3)."
},
"Article 42": {
"heading": "Designation and notification procedure",
"text": "Article 42 \nDesignation and notif ication procedure \n1. Member State s may only designat e conf ormity assessment bodies for which the assessment pursuant to Article 39 \nwas complet ed and which compl y with Annex VII. \n2. Member States shall notify the Commission and the other Member States of the conf ormity assessment bodies they \nhave designated, using the electronic notifi cation tool within the database of notified bodies developed and manage d by \nthe Commission (NANDO). \n3. The notifi cation shall clearly specify , using the codes referred to in paragraph 13 of this Article, the scope of the \ndesignation indicating the conf ormity assessment activities as defined in this Regulation and the types of devices whic h \nthe notified body is author ised to assess and, without prejudice to Article 44, any conditions associated with the \ndesignation. 5.5.2017 L 117/43 Official Jour nal of the European Union EN \n 4. The notifi cation shall be accompan ied by the final assessment repor t of the author ity responsible for notifi ed \nbodies, the final opinion of the joint assessment team refer red to in Article 39(9) and the recommendation of the \nMDCG. Where the notifying Member State does not follow the recommendation of the MDCG, it shall provide a duly \nsubstantiated justif ication. \n5. The notifying Member State shall, without prejudice to Article 44, inform the Commission and the other \nMember States of any conditions associated with the designation and provide documentar y evidence regarding the \narrang ements in place to ensure that the notified body will be monitored regularly and will continue to satisfy the \nrequirements set out in Annex VII. \n6. Within 28 days of the notificati on referred to in paragraph 2, a Member State or the Commission may raise \nwritten objections, setting out its arguments, with regar d either to the notifi ed body or to its monitori ng by the \nauthor ity responsible for notified bodies. Where no objection is raised, the Commission shall publish in NANDO the \nnotificati on within 42 days of its having been notified as refer red to in paragraph 2. \n7. When a Member State or the Commission raises objections in accordance with paragraph 6, the Commission shall \nbring the matter before the MDCG within 10 days of the expir y of the period refer red to in paragraph 6. After \nconsulting the parties involved, the MDCG shall give its opinion at the latest within 40 days of the matt er having been \nbrought before it. Where the MDCG is of the opinion that the notificati on can be accept ed, the Commission shall \npublish in NANDO the notifi cation within 14 days. \n8. Where the MDCG, after having been consulted in accordance with paragraph 7, conf irms the existing objection or \nraises another objection, the notifying Member State shall provide a written response to the MDCG opinion within \n40 days of its receipt. The response shall address the objections raised in the opinion, and set out the reasons for the \nnotifying Member State 's decision to designat e or not designate the conf ormity assessment body . \n9. Where the notifying Member State decides to uphold its decision to designate the conf ormity assessment body , \nhaving given its reasons in accordance with paragraph 8, the Commission shall publish in NANDO the notifi cation \nwithin 14 days of being informed thereof. \n10. When publishing the notificati on in NANDO, the Commission shall also add to the electronic system referred to \nin Article 57 the information relating to the notifi cation of the notifi ed body along with the documents mentioned in \nparagraph 4 of this Article and the opinion and responses referred to in paragraphs 7 and 8 of this Article. \n11. The designation shall become valid the day after the notification is published in NANDO. The published \nnotificati on shall state the scope of lawful conf ormity assessment activity of the notifi ed body . \n12. The conf ormity assessment body concer ned may perform the activities of a notifi ed body only after the \ndesignation has become valid in accordance with paragraph 11. \n13. The Commission shall by 26 November 2017, by means of implementing acts, draw up a list of codes and \ncorresponding types of devices for the purpose of specifying the scope of the designation of notified bodies. Those \nimplementing acts shall be adopt ed in accordance with the examination procedure refer red to in Article 114(3). The \nCommission, after consulting the MDCG, may updat e this list based, inter alia, on information arising from the \ncoordination activities descr ibed in Article 48."
},
"Article 43": {
"heading": "Identification number and list of notified bodies",
"text": "Article 43 \nIdentif ication number and list of notif ied bodies \n1. The Commission shall assign an identif ication number to each notified body for which the notifi cation becomes \nvalid in accordance with Article 42(11). It shall assign a sing le identif ication number even when the body is notified \nunder several Union acts. If they are successfully designated in accordance with this Regulation, bodies notified pursuant \nto Directives 90/385/EEC and 93/42/EEC shall retain the identif ication number assigned to them pursuant to those \nDirectives. \n2. The Commission shall make the list of the bodies notified under this Regulation, including the identification \nnumbers that have been assigned to them and the conf ormity assessment activities as defined in this Regulation and the \ntypes of devices for which they have been notified, accessible to the public in NANDO. It shall also make this list \navailable on the electronic system refer red to in Article 57. The Commission shall ensure that the list is kept up to date . 5.5.2017 L 117/44 Official Jour nal of the European Union EN"
},
"Article 44": {
"heading": "Monitoring and re-assessment of notified bodies",
"text": "Article 44 \nMonito ring and re-assessment of notif ied bodies \n1. Notified bodies shall, without dela y, and at the latest within 15 days, inform the author ity responsible for notifi ed \nbodies of relevant changes which may affect their compl iance with the requirements set out in Annex VII or their ability \nto conduct the conf ormity assessment activities relating to the devices for whic h they have been designat ed. \n2. The author ities responsible for notified bodies shall monitor the notifi ed bodies established on their territory and \ntheir subsidiar ies and subcontractors to ensure ongoing compliance with the requirements and the fulfilment of its \noblig ations set out in this Regulation. Notifie d bodies shall, upon request by their author ity responsible for notified \nbodies, supply all relevant information and documents, required to enable the author ity, the Commission and other \nMember States to verify compliance. \n3. Where the Commission or the author ity of a Member State submits a request to a notified body established on the \nterritory of another Member State relating to a conf ormity assessment carried out by that notifi ed body , it shall send \na copy of that request to the author ity responsible for notified bodies of that other Member State . The notified body \nconcer ned shall respond without dela y and within 15 days at the lates t to the request. The author ity responsible for \nnotified bodies of the Member State in whic h the body is established shall ensure that requests submitted by author ities \nof any other Member State or by the Commission are resolved by the notified body unless there is a legitimate reason \nfor not doing so in which case the matt er may be referred to the MDCG. \n4. At least once a year , the author ities responsible for notified bodies shall re-assess whether the notifi ed bodies \nestablished on their respective territory and, where appropr iate, the subsidiar ies and subcontractors under the responsi \nbility of those notifi ed bodies still satisfy the requirements and fulfil their obligations set out in Annex VII. That review \nshall include an on-site audit of each notifi ed body and, where necessar y, of its subsidiar ies and subcontractor s. \nThe author ity responsible for notifi ed bodies shall conduct its monitoring and assessment activities according to an \nannual assessment plan to ensure that it can effectively monitor the continued compl iance of the notified body with the \nrequirements of this Regulation. That plan shall provide a reasoned sche dule for the frequency of assessment of the \nnotified body and, in particular , associated subsidiar ies and subcontractor s. The author ity shall submit its annual plan \nfor monit oring or assessment for each notified body for which it is responsible to the MDCG and to the Commission. \n5. The monitori ng of notified bodies by the author ity responsible for notifi ed bodies shall include obser ved audits of \nnotified body personnel, including where necessar y any personnel from subsidiar ies and subcontract ors, as that \npersonnel is in the process of conducting quality manage ment system assessments at a manufa cturer's facility . \n6. The monit oring of notifi ed bodies conduct ed by the author ity responsible for notifi ed bodies shall consider data \narising from mark et surveillance, vigilance and post-market surveillance to help guide its activities. \nThe author ity responsible for notified bodies shall provide for a systematic follow-up of compl aints and other \ninformation, including from other Member State s, which may indicate non-fulfilment of the obligations by a notified \nbody or its deviation from common or best practice. \n7. The author ity responsible for notified bodies may in addition to regular monitori ng or on-site assessments conduct \nshor t-notice, unannounced or ‘for-cause ’ reviews if needed to address a particular issue or to verify compl iance. \n8. The author ity responsible for notifi ed bodies shall review the assessments by notified bodies of manufact urers' \ntechnical documentation, in particular the clinical evaluation documentation as further outlined in Article 45. \n9. The author ity responsible for notified bodies shall document and record any findings regar ding non-com pliance of \nthe notifi ed body with the requirements set out in Annex VII and shall monitor the timely implementation of corrective \nand preventive actions. \n10. Three years after notifi cation of a notified body , and again ever y fourth year thereaf ter, a compl ete re-assessment \nto determine whether the notified body still satisfi es the requirements set out in Annex VII shall be conduct ed by the \nauthor ity responsible for notifi ed bodies of the Member State in which the body is established and by a joint assessment \nteam appointed for the purpose of the procedure descr ibed in Articles 38 and 39. 5.5.2017 L 117/45 Official Jour nal of the European Union EN \n 11. The Commission is empowered to adopt delegat ed acts in accordance with Article 115 in order to amend \nparagraph 10 to modify the frequency at whic h the compl ete re-assessment refer red to in that paragraph is to be carried \nout. \n12. The Member States shall repor t to the Commission and to the MDCG, at least once a year, on their monitori ng \nand on-site assessment activities rega rding notified bodies and, where applicable, subsidiar ies and subcontractors. The \nrepor t shall provide details of the outcome of those activities, including activities pursuant to paragraph 7, and shall be \ntreated as confidential by the MDCG and the Commission; however it shall contain a summar y which shall be made \npublicly available. \nThe summar y of the repor t shall be uploaded to the electronic system referred to in Article 57."
},
"Article 45": {
"heading": "Review of notified body assessment of technical documentation and clinical evaluation documentation",
"text": "Article 45 \nReview of notif ied body assessment of technical documentation and clinical evaluation \ndocumentation \n1. The author ity responsible for notified bodies, as part of its ongoing monitori ng of notified bodies, shall review an \nappropr iate number of notifi ed body assessments of manuf acturers' technical documentation, in particular the clinical \nevaluation documentation as refer red to in points (c) and (d) of Section 6.1 of Annex II to verify the conclusions drawn \nby the notified body based on the information present ed by the manufacturer . The reviews by the author ity responsible \nfor notified bodies shall be conduct ed both off-site and on-site. \n2. The sampling of files to be reviewed in accordance with paragraph 1 shall be planned and representative of the \ntypes and risk of devices certified by the notified body , in particular high-r isk devices, and be appropr iately justif ied and \ndocumented in a sampli ng plan, which shall be made available by the author ity responsible for notified bodies to the \nMDCG upon request. \n3. The author ity responsible for notifi ed bodies shall review whether the assessment by the notifi ed body was \nconduct ed appropr iately and shall chec k the procedures used, associated documentation and the conclusions drawn by \nthe notified body . Such checking shall include the technical documentation and clinical evaluation documentation of the \nmanufa cturer upon which the notifi ed body has based its assessment. Such reviews shall be conduct ed utilising CS. \n4. Those reviews shall also form part of the re-assessment of notified bodies in accordance with Article 44(10) and \nthe joint assessment activities refer red to in Article 47(3). The reviews shall be conduct ed utilising appropr iate exper tise. \n5. Based on the repor ts of the reviews and assessments by the author ity responsible for notified bodies or joint \nassessment teams, on input from the mark et surveillance, vigilance and post-market surveillance activities descr ibed in \nChapt er VII, on the continuous monitor ing of technical progress, or on the identif ication of concer ns and emerging \nissues concer ning the safety and performa nce of devices, the MDCG may recommend that the sampli ng, carried out \nunder this Article, cover a greate r or lesser propor tion of the technical documentation and clinical evaluation documen \ntation assessed by a notifi ed body . \n6. The Commission may, by means of implementing acts, adopt measures setting out the detailed arrangements, \nassociated documents for, and coordination of, the review of assessments of technical documentation and clinical \nevaluation documentation, as referred to in this Article. Those imple menting acts shall be adopt ed in accordance with \nthe examination procedure refer red to in Article 114(3)."
},
"Article 46": {
"heading": "Changes to designations and notifications",
"text": "Article 46(2); \n(d) the list of notified bodies referred to in Article 43(2); \n(e) the summar y of the repor t referred to in Article 44(12); \n(f) the notific ations for conf ormity assessments and certificates refer red to in Articles 54(3) and 55(1); \n(g) withdra wal or refusals of applications for the certificates as referred to in Article 53(2) and Section 4.3 of \nAnnex VII; \n(h) the information regarding certificates referred to in Article 56(5); \n(i) the summar y of safety and clinical perf ormance refer red to in Article 32. \n2. The information collated and processed by the electronic system shall be accessible to the compet ent author ities of \nthe Member States, to the Commission, where appropr iate to the notifi ed bodies and where provided elsewhere in this \nregulation or in Regulation (EU) 2017/746 to the public."
},
"Article 47": {
"heading": "Challenge to the competence of notified bodies",
"text": "Article 47 \nChallenge to the competence of notif ied bodies \n1. The Commission, in conjunction with the MDCG, shall inve stigat e all cases where concer ns have been brought to \nits attention regar ding the continued fulfilme nt by a notified body , or of one or more of its subsidiar ies or subcon \ntract ors, of the requirements set out in Annex VII or the oblig ations to which they are subject. It shall ensure that the \nrelevant author ity responsible for notified bodies is informed and is given an oppor tunity to investigat e those concer ns. \n2. The notifying Member State shall provide the Commission, on request, with all information regar ding the \ndesignation of the notified body concer ned. \n3. The Commission, in conjunction with the MDCG, may initiate, as applicable, the assessment procedure descr ibed \nin Article 39(3) and (4), where there is reasonable concer n about the ongoing compl iance of a notifi ed body or \na subsidiar y or subcontractor of the notifi ed body with the requirements set out in Annex VII and where the inve sti\ngation by the author ity responsible for notified bodies is not deemed to have fully addressed the concer ns or upon \nrequest of the author ity responsible for notified bodies. The repor ting and outcome of that assessment shall follow the \nprinciples of Article 39. Alternatively , depending on the sever ity of the issue, the Commission, in conjunction with the \nMDCG, may request that the author ity responsible for notified bodies allow the participation of up to two exper ts from \nthe list established pursuant to Article 40 in an on-site assessment as part of the planned monitori ng and assessment \nactivities in accordance with Article 44 and as outlined in the annual assessment plan descr ibed in Article 44(4). \n4. Where the Commission ascer tains that a notifi ed body no long er meets the requirements for its designation, it \nshall inform the notifying Member State according ly and request it to take the necessar y corrective measures, including \nthe suspension, restr iction or withdrawal of the designation if necessar y. \nWhere the Member State fails to take the necessar y corrective measures, the Commission may, by means of \nimplementing acts, suspend, restr ict or withdraw the designation. Those implementing acts shall be adopt ed in \naccordance with the examination procedure referred to in Article 114(3). It shall notify the Member State concer ned of \nits decision and update NANDO and the electronic system refer red to in Article 57. \n5. The Commission shall ensure that all confidential information obtained in the course of its investigat ions is treated \naccording ly."
},
"Article 48": {
"heading": "Peer review and exchange of experience between authorities responsible for notified bodies",
"text": "Article 48 \nPeer review and exchange of exper ience betw een author ities responsible for notif ied bodies \n1. The Commission shall provide for the organisation of exchang e of exper ience and coordination of administrative \npractice between the author ities responsible for notified bodies. Such exchang e shall cover elements including: \n(a) development of best practice documents relating to the activities of the author ities responsible for notified bodies; 5.5.2017 L 117/48 Official Jour nal of the European Union EN \n (b) development of guidance documents for notifi ed bodies in relation to the imp lementation of this Regulation; \n(c) training and qualifi cation of the exper ts refer red to in Article 40; \n(d) monitori ng of trends relating to changes to notifi ed body designations and notificati ons and trends in certificate \nwithdrawa ls and transfer s between notifi ed bodies; \n(e) monitori ng of the application and applicability of scope codes refer red to in Article 42(13); \n(f) development of a mec hanism for peer reviews between author ities and the Commission; \n(g) methods of communication to the public on the monitori ng and surveillance activities of author ities and the \nCommission on notifi ed bodies. \n2. The author ities responsible for notified bodies shall participate in a peer review ever y third year through the \nmech anism developed pursuant to paragraph 1 of this Article. Such reviews shall normally be conducted in parallel with \nthe on-site joint assessments descr ibed in Article 39. Alter natively , an author ity may mak e the choice of having such \nreviews take place as part of its monitori ng activities referred to in Article 44. \n3. The Commission shall participate in the organisati on and provide suppor t to the implementation of the peer \nreview mec hanism. \n4. The Commission shall compi le an annual summar y repor t of the peer review activities, whic h shall be made \npublicly available. \n5. The Commission may, by means of imple menting acts, adopt measures setting out the detailed arrange ments and \nrelat ed documents for the peer review mecha nism and training and qualification as refer red to in paragraph 1 of this \nArticle. Those implementing acts shall be adop ted in accordance with the examination procedure refer red to in"
},
"Article 49": {
"heading": "Coordination of notified bodies",
"text": "Article 49 \nCoordination of notif ied bodies \nThe Commission shall ensure that appropr iate coordination and cooperation between notified bodies is put in place and \noperat ed in the form of a coordination group of notified bodies in the field of medical devices, including in vitro \ndiagnostic medical devices. This group shall meet on a regular basis and at least annually . \nThe bodies notified under this Regulation shall participate in the work of that group. \nThe Commission may establish the specific arrang ements for the functioning of the coordination group of notified \nbodies."
},
"Article 5": null,
"Article 50": {
"heading": "List of standard fees",
"text": "Article 50 \nList of standard fees \nNotifie d bodies shall establish lists of their standard fees for the conf ormity assessment activities that they carry out and \nshall make those lists publicly available. \nCHAPTER V \nCLASSIFIC ATION AND CONFORMIT Y ASSESSMENT \nSECTION 1 \nClassification"
},
"Article 51": null,
"Article 52": null,
"Article 53": null,
"Article 54": null,
"Article 55": null,
"Article 56": null,
"Article 57": null,
"Article 58": null,
"Article 59": null,
"Article 6": null,
"Article 60": null,
"Article 61": null,
"Article 62": null,
"Article 63": null,
"Article 64": null,
"Article 65": null,
"Article 66": null,
"Article 67": null,
"Article 68": null,
"Article 69": null,
"Article 7": null,
"Article 70": null,
"Article 71": null,
"Article 72": null,
"Article 73": null,
"Article 74": null,
"Article 75": null,
"Article 76": null,
"Article 77": null,
"Article 78": null,
"Article 79": null,
"Article 8": null,
"Article 80": null,
"Article 81": null,
"Article 82": null,
"Article 83": null,
"Article 84": null,
"Article 85": null,
"Article 86": null,
"Article 87": null,
"Article 88": null,
"Article 89": null,
"Article 9": null,
"Article 90": null,
"Article 91": null,
"Article 92": null,
"Article 93": null,
"Article 94": null,
"Article 95": null,
"Article 96": null,
"Article 97": null,
"Article 98": null,
"Article 99": null
},
"title": "Notified bodies"
}
|
{
"text": "out in Sections 14 and 15 conf orm to the type descr ibed in the EU type-examination certificate and meet the \nrequirements of this Regulation which apply to them. \n12. The manufacturer shall take all the measures necessar y to ensure that the manufa ctur ing process produces \ndevices whic h conf orm to the type descr ibed in the EU type-examination certificate and to the requirements of \nthe Regulation which apply to them. Prior to the start of manufacture, the manufacturer shall prepare documents \ndefining the manufa ctur ing process, in particular as regards sterilis ation where necessar y, together with all \nroutine, pre-established procedures to be implemented to ensure homog eneous production and, where \nappropr iate, conf ormity of the devices with the type descr ibed in the EU type-examination certificate and with \nthe requirements of this Regulation which apply to them. \nIn addition, for devices placed on the mark et in a steri le condition, and only for those aspects of the manuf actur \ning process designed to secure and maintain steri lity, the manufacturer shall apply the provisions of Sections 6 \nand 7. \n13. The manufa cturer shall under take to institute and keep up to date a post-market surveillance plan, including \na PMCF plan, and the procedures ensur ing compliance with the oblig ations of the manufact urer resulting from \nthe provisions on vigilance and post-market surveillance system set out in Chapt er VII. \n14. The notified body shall carry out the appropr iate examinations and tests in order to verify the conf ormity of the \ndevice with the requirements of the Regulation by examining and testing ever y product as specified in \nSection 15. \nThe examinations and tests referred to in the first paragraph of this Section shall not apply to aspects of the \nmanufactur ing process designed to secure steri lity. \n15. Verification by examination and testing of ever y product \n15.1. Ever y device shall be examined individually and the appropr iate physical or laboratory tests as defined in the \nrelevant standard or standards refer red to in Article 8, or equivalent tests and assessments, shall be carried out in \norder to verify, where appropr iate, the conf ormity of the devices with the type descr ibed in the EU type- \nexamination certificate and with the requirements of this Regulation whic h apply to them. 5.5.2017 L 117/159 Official Jour nal of the European Union EN \n 15.2. The notified body shall affix, or have affixed, its identif ication number to each appro ved device and shall draw \nup an EU product verification certificate relating to the tests and assessments carried out. \n16. Batch verification in the case of devices incor porating, as an integral part, a medicinal substance whic h, if used \nseparately , would be considered to be a medicinal product derived from human blood or human plasma refer red \nto in Article 1(8). \nUpon compl eting the manufacture of each batch of devices that incor porat e, as an integral part, a medicinal \nsubstance which , if used separately , would be considered to be a medicinal product derived from human blood \nor human plasma referred to in the first subparagraph of Article 1(8), the manufacturer shall inform the notifi ed \nbody of the release of the batch of devices and send it the official certificate concer ning the release of the batch \nof human blood or plasma derivative used in the device, issued by a Member State laboratory or a laborat ory \ndesignated for that purpose by a Member State in accordance with Article 114(2) of Directive 2001/83/EC. \n17. Administrative provisions \nThe manufa cturer or its author ised representative shall, for a period ending no sooner than 10 years, and in the \ncase of implantable devices no sooner than 15 years, after the last device has been placed on the market, keep at \nthe disposal of the compet ent author ities: \n— the EU declaration of conf ormity , \n— the documentation refer red to in Section 12, \n— the certificate refer red to in Section 15.2, and \n— the EU type-examination certificate refer red to in Annex X. \nSection 8 of Annex IX shall apply . \n18. Application to class IIa devices \n18.1. By way of deroga tion from Section 11, by virtue of the EU declaration of conf ormity the manuf acturer shall be \ndeemed to ensure and to declare that the class IIa devices in question are manuf actured in conf ormity with the \ntechnical documentation refer red to in Annex es II and III and meet the requirements of this Regulation which \napply to them. \n18.2. The verification conducted by the notified body in accordance with Section 14 is intended to confir m the \nconf ormity of the class IIa devices in question with the technical documentation refer red to in Annex es II and III \nand with the requirements of this Regulation whic h apply to them. \n18.3. If the verification refer red to in Section 18.2 conf irms that the class IIa devices in question conf orm to the \ntechnical documentation refer red to in Annex es II and III and meet the requirements of this Regulation which \napply to them, the notified body shall issue a certificate pursuant to this Part of this Annex. \n18.4. By way of deroga tion from Section 17, the manufacturer or its author ised representative shall, for a period \nending no sooner than 10 years after the last device has been placed on the mark et, keep at the disposal of the \ncompet ent author ities: \n— the EU declaration of conf ormity , \n— the technical documentation refer red to in Annexes II and III, and \n— the certificate refer red to in Section 18.3. \nSection 8 of Annex IX shall apply . 5.5.2017 L 117/160 Official Jour nal of the European Union EN",
"title": "Annex IV, shall be deemed to ensure and to declare that the devices whic h have been subject to the procedure set"
}
|
{
"articles": {
"Article 1": null,
"Article 10": null,
"Article 100": null,
"Article 101": null,
"Article 102": null,
"Article 103": null,
"Article 104": null,
"Article 105": null,
"Article 106": null,
"Article 107": null,
"Article 108": null,
"Article 109": null,
"Article 11": null,
"Article 110": null,
"Article 111": null,
"Article 112": null,
"Article 113": null,
"Article 114": null,
"Article 115": null,
"Article 116": null,
"Article 117": null,
"Article 118": null,
"Article 119": null,
"Article 12": null,
"Article 120": null,
"Article 121": null,
"Article 122": null,
"Article 123": null,
"Article 13": null,
"Article 14": null,
"Article 15": null,
"Article 16": null,
"Article 17": null,
"Article 18": null,
"Article 19": null,
"Article 2": null,
"Article 20": null,
"Article 21": null,
"Article 22": null,
"Article 23": null,
"Article 24": null,
"Article 25": null,
"Article 26": null,
"Article 27": null,
"Article 28": null,
"Article 29": null,
"Article 3": null,
"Article 30": null,
"Article 31": null,
"Article 32": null,
"Article 33": null,
"Article 35": null,
"Article 36": null,
"Article 37": null,
"Article 38": null,
"Article 39": null,
"Article 4": null,
"Article 40": null,
"Article 41": null,
"Article 42": null,
"Article 43": null,
"Article 44": null,
"Article 45": null,
"Article 46": null,
"Article 47": null,
"Article 48": null,
"Article 49": null,
"Article 5": null,
"Article 50": null,
"Article 51": {
"heading": "Classification of devices",
"text": "Article 51 \nClassif ication of devices \n1. Devices shall be divided into classes I, IIa, IIb and III, taking into account the intended purpose of the devices and \ntheir inherent risks. Classification shall be carried out in accordance with Annex VIII. 5.5.2017 L 117/49 Official Jour nal of the European Union EN \n 2. Any dispute between the manuf acturer and the notifi ed body concer ned, arising from the application of \nAnnex VIII, shall be referred for a decision to the compet ent author ity of the Member State in whic h the manufacturer \nhas its register ed place of business. In cases where the manufacturer has no register ed place of business in the Union and \nhas not yet designat ed an author ised representative, the matt er shall be refer red to the compe tent author ity of the \nMember State in which the author ised representative refer red to in the last indent of point (b) of the second \nparagraph of Section 2.2 of Annex IX has its register ed place of business. Where the notified body concer ned is \nestablished in a Member State other than that of the manufacturer , the compet ent author ity shall adopt its decision after \nconsultation with the compet ent author ity of the Member State that designate d the notified body . \nThe compet ent author ity of the Member State in whic h the manuf acturer has its registere d place of business shall notify \nthe MDCG and the Commission of its decision. The decision shall be made available upon request. \n3. At the request of a Member State the Commission shall after consulting the MDCG, decide, by means of \nimplementing acts, on the following: \n(a) application of Annex VIII to a given device, or categor y or group of devices, with a view to deter mining the classifi \ncation of such devices; \n(b) that a device, or categor y or group of devices, shall for reasons of public health based on new scientific evidence, or \nbased on any information whic h becomes available in the course of the vigilance and mark et surveillance activities \nbe reclassif ied, by way of deroga tion from Annex VIII. \n4. The Commission may also, on its own initiative and after consulting the MDCG, decide, by means of \nimplementing acts, on the issues refer red to in points (a) and (b) of paragraph 3. \n5. In order to ensure the unif orm application of Annex VIII, and taking account of the relevant scientifi c opinions of \nthe relevant scientifi c committees, the Commission may adopt implementing acts to the extent necessar y to resolve \nissues of diverg ent interpretat ion and of practical application. \n6. The implementing acts referred to in paragraphs 3, 4 and 5 of this Article shall be adopt ed in accordance with the \nexamination procedure refer red to in Article 114(3). \nSECTION 2 \nConf ormity assessment"
},
"Article 52": {
"heading": "Conformity assessment procedures",
"text": "Article 52(10). \n7. After carrying out the evaluation in accordance with paragraph 3 of this Article, the evaluating compet ent \nauthor ity shall, through the electronic system refer red to in Article 92, inform, without dela y, the other compet ent \nauthor ities of the corrective action taken or envisaged by the manuf acturer or required of it to minimise the risk of \nrecur rence of the serious incident, including information on the underlying events and the outcome of its assessment. \n8. The manuf acturer shall ensure that information about the field safety corrective action taken is brought without \ndela y to the attention of users of the device in question by means of a field safet y notice. The field safety notice shall be \nedited in an official Union languag e or languages determined by the Member State in whic h the field safety corrective \naction is taken. Excep t in cases of urgency , the conte nt of the draf t field safety notice shall be submitte d to the \nevaluating compet ent author ity or, in the cases refer red to in paragraph 9, to the coordinating compet ent author ity to \nallow it to make comments. Unless duly justif ied by the situation of the individual Member State, the conte nt of the field \nsafety notice shall be consistent in all Member State s. \nThe field safety notice shall allow the correct identif ication of the device or devices involved, in particular by including \nthe relevant UDIs, and the correct identif ication, in particular , by including the SRN, if already issued, of the \nmanufa cturer that has under taken the field safet y corrective action. The field safety notice shall explain, in a clear \nmanner , without understating the level of risk, the reasons for the field safet y corrective action with reference to the \ndevice malfunction and associated risks for patients, users or other persons, and shall clearly indicate all the actions to \nbe taken by users. \nThe manuf acturer shall enter the field safety notice in the electronic system referred to in Article 92 through which that \nnotice shall be accessible to the public. \n9. The compe tent author ities shall actively participate in a procedure in order to coordinate their assessments refer red \nto in paragraph 3 in the following cases: \n(a) where there is concer n regarding a particular serious incident or cluster of serious incidents relating to the same \ndevice or type of device of the same manufacturer in more than one Member State; 5.5.2017 L 117/75 Official Jour nal of the European Union EN \n (b) where the appropr iateness of a field safety corrective action that is proposed by a manuf acturer in more than one \nMember State is in question. \nThat coordinated procedure shall cover the following: \n— designation of a coordinating compet ent author ity on a case by case basis, when required; \n— defining the coordinat ed assessment process, including the tasks and responsibilities of the coordinating compet ent \nauthor ity and the involvement of other compet ent author ities. \nUnless other wise agreed between the compe tent author ities, the coordinating compet ent author ity shall be the \ncompet ent author ity of the Member State in whic h the manufa cturer has its registered place of business. \nThe coordinating compet ent author ity shall, through the electronic system referred to in Article 92, inform the \nmanufa cturer , the other compet ent author ities and the Commission that it has assumed the role of coordinating \nauthor ity. \n10. The designation of a coordinating compet ent author ity shall not affect the rights of the other compet ent \nauthor ities to perf orm their own assessment and to adopt measures in accordance with this Regulation in order to \nensure the prote ction of public health and patient safety . The coordinating compet ent author ity and the Commission \nshall be kept informed of the outcome of any such assessment and the adopt ion of any such measures. \n11. The Commission shall provide administrative suppor t to the coordinating compet ent author ity in the \naccompl ishment of its tasks under this Chapt er."
},
"Article 53": {
"heading": "Involvement of notified bodies in conformity assessment procedures",
"text": "Article 53 \nInvolvement of notif ied bodies in confor mity assessment procedures \n1. Where the conf ormity assessment procedure requires the involvement of a notified body , the manuf acturer may \napply to a notified body of its choice, provided that the chosen notified body is designate d for conf ormity assessment \nactivities relat ed to the types of devices concer ned. The manuf acturer may not lodg e an application in parallel with \nanother notified body for the same conf ormity assessment procedure. \n2. The notifi ed body concer ned shall, by means of the electronic system refer red to in Article 57, inform the other \nnotified bodies of any manufacturer that withdra ws its application prior to the notified body's decision regar ding the \nconf ormity assessment. \n3. When applying to a notified body under paragraph 1, manufacturers shall declare whether they have withdra wn \nan application with another notified body prior to the decision of that notified body and provide information about any \nprevious application for the same conf ormity assessment that has been refused by another notifi ed body . \n4. The notified body may require any information or data from the manuf acturer , which is necessar y in order to \nproperly conduct the chosen conf ormity assessment procedure. \n5. Notified bodies and the personnel of notified bodies shall carry out their conf ormity assessment activities with the \nhighest degree of profess ional integr ity and the requisite technical and scientific compet ence in the specifi c field and \nshall be free from all pressures and inducements, particularly financial, whic h might influence their judg ement or the \nresults of their conf ormity assessment activities, especially as regards persons or groups with an inter est in the results of \nthose activities."
},
"Article 54": {
"heading": "Clinical evaluation consultation procedure for certain class III and class IIb devices",
"text": "Article 54(1) and Article 61(2) and Section 5.1 of Annex IX or Section 6 of Annex X, as applicable. \n10. Exper t panels and exper t laborat ories may have the following task s, depending on the requisit e needs: \n(a) to provide scientific, technical and clinical assistance to the Commission and the MDCG in relation to the implemen \ntation of this Regulation; \n(b) to contr ibut e to the development and maint enance of appropr iate guidance and CS for: \n— clinical investig ations, \n— clinical evaluation and PMCF , \n— performance studies, \n— performance evaluation and post-market perf ormance follow-up, \n— physico-chem ical charact erisation, and \n— microbiological, biocompat ibility , mech anical, electr ical, electronic or non-clinical toxicological testin g \nfor specific devices, or a categor y or group of devices, or for specifi c hazards related to a categor y or group of \ndevices; \n(c) to develop and review clinical evaluation guidance and performa nce evaluation guidance for performa nce of \nconf ormity assessment in line with the state of the art with regar d to clinical evaluation, perf ormance evaluation, \nphysico-chemical character isation, and microbiological, biocom patibility , mechanical, electr ical, electronic or non- \nclinical toxicological testing; \n(d) to contr ibute to the development of standards at international level, ensur ing that such standards reflect the state of \nthe art; \n(e) to provide opinions in response to consultations by manufacturers in accordance with Article 61(2), notifi ed bodies \nand Member States in accordance with paragraphs 11 to 13 of this Article. \n(f) to contr ibut e to identification of concer ns and emerging issues on the safety and performa nce of medical devices; \n(g) to provide views in accordance with Article 48(4) of Regulation (EU) 2017/746 on the performa nce evaluation of \ncertain in vitro diagnostic medical devices. \n11. The Commission, shall facilitate the access of Member States and notified bodies and manufa cturers to advice \nprovided by exper t panels and exper t laborat ories concer ning, inter alia, the criteria for an appropr iate data set for \nassessment of the conf ormity of a device, in particular with regard to the clinical data required for clinical evaluation, \nwith regar d to physico-c hemical charact erisation, and with regar d to microbiological, biocom patibility , mechanical, \nelectr ical, electronic and non-clinical toxicological testing. \n12. When adopting its scientific opinion in accordance with paragraph 9, the members of the exper t panels shall use \ntheir best endeav ours to reach consensus. If consensus cannot be reach ed, the exper t panels shall decide by a majority of \ntheir members, and the scientific opinion shall mention the diverg ent positions and the grounds on which they are \nbased. \nThe Commission shall publish the scientifi c opinion and advice delivered in accordance with paragraphs 9 and 11 of \nthis Article, ensur ing consideration of aspects of conf identiality as set out in Article 109. The clinical evaluation \nguidance refer red to in point (c) of paragraph 10 shall be published following consultation with the MDCG. \n13. The Commission may require manufacturers and notifi ed bodies to pay fees for the advice provided by exper t \npanels and exper t laboratories. The structure and the level of fees as well as the scale and structure of reco verable costs \nshall be adopt ed by the Commission by means of implementing acts, taking into account the objectives of the adequat e \nimplementation of this Regulation, prot ection of health and safety, suppor t of inno vation and cost-effe ctiveness and the \nnecessity to achieve active participation in the exper t panels. Those implementing acts shall be adopt ed in accordance \nwith the examination procedure refer red to in Article 114(3). 5.5.2017 L 117/85 Official Jour nal of the European Union EN \n 14. The fees payable to the Commission in accordance with the procedure under paragraph 13 of this Article shall \nbe set in a transparent manner and on the basis of the costs for the services provided. The fees payable shall be reduced \nin the case of a clinical evaluation consultation procedure initiated in accordance with point (c) of Section 5.1 of \nAnnex IX involving a manufa cturer who is a micro, small or medium-sized enterprise within the meaning of \nRecommendation 2003/361/EC. \n15. The Commission is empo wered to adopt delegat ed acts in accordance with Article 115 to amend the tasks of \nexper t panels and exper t laboratori es refer red to in paragraph 10 of this Article."
},
"Article 55": {
"heading": "Mechanism for scrutiny of conformity assessments of certain class III and class IIb devices",
"text": "Article 55 \nMechanism for scrutiny of confor mity assessments of certain class III and class IIb devices \n1. A notified body shall notify the compet ent author ities of certificates it has grant ed to devices for which the \nconf ormity assessment has been perf ormed pursuant to Article 54(1). Such notifi cation shall take place through the \nelectronic system referred to in Article 57 and shall include the summar y of safety and clinical perf ormance pursuant to"
},
"Article 56": {
"heading": "Certificates of conformity",
"text": "Article 56 \nCer tificates of confo rmity \n1. The certificates issued by the notified bodies in accordance with Annex es IX, X and XI shall be in an official Union \nlanguag e determined by the Member State in which the notified body is established or other wise in an official Union \nlanguag e acceptab le to the notifi ed body . The minimum cont ent of the certificates shall be as set out in Annex XII. \n2. The certificates shall be valid for the period they indicate, whic h shall not exceed five years. On application by the \nmanufa cturer , the validity of the certificate may be extende d for further periods, each not exceeding five years, based on \na re-assessment in accordance with the applicable conf ormity assessment procedures. Any supplement to a certificate \nshall remain valid as long as the certificate which it supplements is valid. \n3. Notified bodies may imp ose restr ictions to the intended purpose of a device to certain groups of patients or \nrequire manufacturers to under take specif ic PMCF studies pursuant to Part B of Annex XIV. 5.5.2017 L 117/53 Official Jour nal of the European Union EN \n 4. Where a notifi ed body finds that the requirements of this Regulation are no longer met by the manuf acturer , it \nshall, taking account of the principle of propor tionality , suspend or withdra w the certificate issued or impose any \nrestr ictions on it unless compl iance with such requirements is ensured by appropr iate corrective action taken by the \nmanufa cturer within an appropr iate deadline set by the notified body . The notified body shall give the reasons for its \ndecision. \n5. The notified body shall enter in the electronic system refer red to in Article 57 any information rega rding \ncertificates issued, including amendments and supplements thereto, and regar ding suspended, reinstated , withdrawn or \nrefused certificates and restr ictions imposed on certificates. Such information shall be accessible to the public. \n6. In the light of technical progress, the Commission is empowered to adopt delegat ed acts in accordance with"
},
"Article 57": {
"heading": "Electronic system on notified bodies and on certificates of conformity",
"text": "Article 57 \nElectronic system on notif ied bodies and on certificates of conformity \n1. The Commission, after consulting the MDCG, shall set up and manage an electronic system to collat e and process \nthe following information: \n(a) the list of subsidiar ies referred to in Article 37(3); \n(b) the list of exper ts referred to in Article 40(2); \n(c) the information relating to the notifi cation refer red to in Article 42(10) and the amended notifications refer red to in"
},
"Article 58": {
"heading": "Voluntary change of notified body",
"text": "Article 58 \nVolunta ry change of notif ied body \n1. In cases where a manufacturer term inates its contract with a notifi ed body and enters into a contract with another \nnotified body in respect of the conf ormity assessment of the same device, the detailed arrang ements for the change of \nnotified body shall be clearly defined in an agreement between the manuf acturer , the incoming notified body and, where \npracticable the outgoing notified body . That agreement shall cover at least the following aspects: \n(a) the date on whic h the certificates issued by the outgoing notifi ed body become invalid; \n(b) the date until which the identif ication number of the outgoing notifi ed body may be indicated in the information \nsupplied by the manufa cturer , including any promotional mate rial; \n(c) the transfer of documents, including conf identiality aspects and proper ty rights; \n(d) the date after which the conf ormity assessment tasks of the outgoing notifi ed body is assigned to the incoming \nnotified body ; \n(e) the last serial number or lot number for whic h the outgoing notified body is responsible. \n2. The outgoing notifi ed body shall withdra w the certificates it has issued for the device concer ned on the date on \nwhic h they become invalid. 5.5.2017 L 117/54 Official Jour nal of the European Union EN"
},
"Article 59": {
"heading": "Derogation from the conformity assessment procedures",
"text": "Article 59 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council (2) or, once \na delegat ed act has been adopt ed by the Commission pursuant to the first subparagraph of Article 5(3) of \nRegulation (EU) No 528/2012 of the European Parliament and the Council (3), in accordance with the \ncriteria that are relevant to human health amongst the criteria established therein. \n10.4.2. Justifi cation regarding the presence of CMR and/or endocr ine-disr upti ng substances \nThe justification for the presence of such substances shall be based upon: \n(a) an analysis and estimation of potential patient or user exposure to the substance; \n(b) an analysis of possible alternati ve substances, mater ials or designs, including, where available, information \nabout independent research, peer -reviewed studies, scientific opinions from relevant scientific committees \nand an analysis of the availability of such alternati ves; \n(c) argumentation as to why possible substance and/ or mater ial substitutes, if available, or design change s, if \nfeasible, are inappropr iate in relation to maintaining the functionality , performa nce and the benefi t-risk \nratios of the product ; including taking into account if the intende d use of such devices includes treatment \nof children or treatment of pregnant or breastf eeding women or treatment of other patient groups \nconsidered particularly vulnerable to such substances and/or mate rials; and \n(d) where applicable and available, the latest relevant scientific committee guidelines in accordance with \nSections 10.4.3. and 10.4.4. \n10.4.3. Guidelines on phthalat es \nFor the purposes of Section 10.4., the Commission shall, as soon as possible and by 26 May 2018, provide the \nrelevant scientific committe e with a mandate to prepare guidelines that shall be ready before 26 May 2020. The \nmandate for the committee shall encomp ass at least a benefit-r isk assessment of the presence of phthalates \nwhich belong to either of the groups of substances referred to in points (a) and (b) of Section 10.4.1. The \nbenefi t-risk assessment shall take into account the intende d purpose and cont ext of the use of the device, as \nwell as any available altern ative substances and alternative mat erials, designs or medical treatments. When \ndeemed appropr iate on the basis of the latest scientifi c evidence, but at least ever y five years, the guidelines \nshall be update d. 5.5.2017 L 117/96 Official Jour nal of the European Union EN \n(1)Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and \npackaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending \nRegulation (EC) No 1907/2006 ( OJ L 353, 31.12.2008, p. 1). \n(2)Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concer ning the Registration, \nEvaluation, Authorisation and Restr iction of Chemicals (REA CH) (OJ L 396, 30.12.2006, p. 1). \n(3)Regulation (EU) No 528/2012 of the European Parliament and the Council of 22 May 2012 concer ning the making avai lable on the \nmarket of and use of biocidal products (OJ L 167, 27.6.2012, p. 1). \n 10.4.4. Guidelines on other CMR and endocr ine-disr upti ng substances \nSubsequently , the Commission shall mandate the relevant scientifi c committee to prepare guidelines as refer red \nto in Section 10.4.3. also for other substances refer red to in points (a) and (b) of Section 10.4.1., where \nappropr iate. \n10.4.5. Labelling \nWhere devices, parts thereof or mater ials used therein as refer red to in Section 10.4.1. contain substances \nrefer red to in points (a) or (b) of Section 10.4.1. in a concentration above 0,1 % weight by weight (w/w), the \npresence of those substances shall be labelled on the device itself and/or on the packag ing for each unit or, \nwhere appropr iate, on the sales packag ing, with the list of such substances. If the intended use of such devices \nincludes treatment of children or treatment of pregnant or breastf eeding women or treatment of other patient \ngroups considered particularly vulnerable to such substances and/or mate rials, information on residual risks for \nthose patient groups and, if applicable, on appropr iate precautionar y measures shall be given in the \ninstr uctions for use. \n10.5. Devices shall be designed and manufactured in such a way as to reduce as far as possible the risks posed by the \nunintentional ingress of substances into the device taking into account the device and the nature of the \nenvi ronment in which it is intended to be used. \n10.6. Devices shall be designed and manuf actured in such a way as to reduce as far as possible the risks linked to the \nsize and the proper ties of particles whic h are or can be released into the patient's or user's body , unless they \ncome into contact with intact skin only . Special attention shall be given to nanomater ials. \n11. Infection and microbial contamination \n11.1. Devices and their manuf actur ing processes shall be designed in such a way as to eliminate or to reduce as far as \npossible the risk of infection to patients, users and, where applicable, other persons. The design shall: \n(a) reduce as far as possible and appropr iate the risks from unintended cuts and pricks, such as needle stick \ninjur ies, \n(b) allow easy and safe handling, \n(c) reduce as far as possible any microbial leakage from the device and/or microbial exposure during use, and \n(d) prevent microbial contamination of the device or its content such as specimens or fluids. \n11.2. Where necessar y devices shall be designed to facilitat e their safe cleaning, disinfection, and/or re-st erilisation. \n11.3. Devices labelled as having a specifi c microbial state shall be designed, manuf actured and packag ed to ensure \nthat they remain in that state when placed on the mark et and remain so under the transpor t and storag e \nconditions specifi ed by the manufacturer . \n11.4. Devices delivered in a sterile state shall be designed, manufa ctured and packag ed in accordance with \nappropr iate procedures, to ensure that they are sterile when placed on the mark et and that, unless the \npackag ing which is intended to maintain their sterile condition is damaged, they remain sterile, under the \ntranspor t and stora ge conditions specified by the manufacturer , until that packaging is opened at the point of \nuse. It shall be ensured that the integr ity of that packaging is clearly evident to the final user . \n11.5. Devices labelled as sterile shall be processed, manufactured, packag ed and, sterilis ed by means of appropr iate, \nvalidate d methods. \n11.6. Devices intended to be sterilised shall be manuf actured and packag ed in appropr iate and controlled conditions \nand facilities. \n11.7. Packaging syste ms for non-sterile devices shall maintain the integr ity and cleanliness of the product and, where \nthe devices are to be sterilised prior to use, minimise the risk of microbial contamination; the packag ing system \nshall be suitable taking account of the method of sterilisation indicated by the manuf acturer . 5.5.2017 L 117/97 Official Jour nal of the European Union EN \n 11.8. The labelling of the device shall distinguish between identical or similar devices placed on the mark et in both \na sterile and a non-steri le condition additional to the symbol used to indicate that devices are steri le. \n12. Devices incor porating a substance considered to be a medicinal product and devices that are compo sed of \nsubstances or of combinations of substances that are absorbed by or locally dispersed in the human body . \n12.1. In the case of devices referred to in the first subparagraph of Article 1(8), the quality , safety and usefulness of \nthe substance whic h, if used separately , would be considered to be a medicinal product within the meaning of \npoint (2) of Article 1 of Directive 2001/83/EC, shall be verified by analogy with the methods specified in \nAnnex I to Directive 2001/83/EC, as required by the applicable conf ormity assessment procedure under this \nRegulation. \n12.2. Devices that are compo sed of substances or of combinations of substances that are intended to be introduced \ninto the human body , and that are absorbed by or locally dispersed in the human body shall comply , where \napplicable and in a manner limited to the aspects not covered by this Regulation, with the relevant \nrequirements laid down in Annex I to Directive 2001/83/EC for the evaluation of absor ption, distr ibution, \nmetabolism, excre tion, local tolerance, toxicity , intera ction with other devices, medicinal products or other \nsubstances and potential for adverse reactions, as required by the applicable conf ormity assessment procedure \nunder this Regulation. \n13. Devices incor porating mater ials of biological origin \n13.1. For devices manufactured utilising derivatives of tissues or cells of human origin whic h are non-viable or are \nrendered non-viable covered by this Regulation in accordance with point (g) of Article 1(6), the following shall \napply: \n(a) donation, procurement and testing of the tissues and cells shall be done in accordance with \nDirective 2004/23/EC; \n(b) processing, preser vation and any other handling of those tissues and cells or their derivatives shall be \ncarried out so as to provide safety for patients, users and, where applicable, other persons. In particular , \nsafety with regard to viruses and other transmissible agents shall be addressed by appropr iate methods of \nsourcing and by implementation of validat ed methods of elimination or inactivation in the course of the \nmanufactur ing process; \n(c) the traceability system for those devices shall be compl ementar y and compati ble with the traceability and \ndata protection requirements laid down in Directive 2004/23/EC and in Directive 2002/98/EC. \n13.2. For devices manuf actured utilising tissues or cells of animal origin, or their derivatives, whic h are non-viable or \nrendered non-viable the following shall apply: \n(a) where feasible taking into account the animal species, tissues and cells of animal origin, or their derivatives, \nshall originat e from animals that have been subjected to veterinar y controls that are adapt ed to the \nintended use of the tissues. Information on the geographical origin of the animals shall be retained by \nmanufacturers; \n(b) sourcing, processing, preser vation, testing and handling of tissues, cells and substances of animal origin, or \ntheir derivatives, shall be carried out so as to provide safety for patients, users and, where applicable, other \npersons. In particular safety with regar d to viruses and other transmissible agents shall be addressed by \nimplementation of validate d methods of elimination or viral inactivation in the course of the manufactur ing \nprocess, excep t when the use of such methods would lead to unaccept able degradation compromising the \nclinical benefit of the device; \n(c) in the case of devices manufactured utilising tissues or cells of animal origin, or their derivatives, as refer red \nto in Regulation (EU) No 722/2012 the particular requirements laid down in that Regulation shall apply . \n13.3. For devices manuf actured utilising non-viable biological substances other than those refer red to in \nSections 13.1 and 13.2, the processing, preser vation, testing and handling of those substances shall be carried \nout so as to provide safety for patients, users and, where applicable, other persons, including in the waste \ndisposal chain. In particular , safety with regar d to viruses and other transmissible agents shall be addressed by \nappropr iate methods of sourcing and by implementation of validat ed methods of elimination or inactivation in \nthe course of the manufactur ing process. 5.5.2017 L 117/98 Official Jour nal of the European Union EN \n 14. Constr uction of devices and inter action with their environment \n14.1. If the device is intended for use in combination with other devices or equipment the whole combination, \nincluding the connection system shall be safe and shall not impair the specifi ed perf ormance of the devices. \nAny restr ictions on use applying to such combinations shall be indicate d on the label and/or in the instr uctions \nfor use. Connections which the user has to handle, such as fluid, gas transfer , electr ical or mechanical coupling, \nshall be designed and constr ucted in such a way as to minimise all possible risks, such as misconnection. \n14.2. Devices shall be designed and manufactured in such a way as to remo ve or reduce as far as possible: \n(a) the risk of injur y, in connection with their physical features, including the volume/pressure ratio, \ndimensional and where appropr iate ergonomic features; \n(b) risks connected with reasonably foreseeable external influences or environmental conditions, such as \nmagnetic fields, external electr ical and electromagnetic effects, electrostatic disc harge, radiation associated \nwith diagnostic or therapeutic procedures, pressure, humidity , temperature, variations in pressure and \nacceleration or radio signal interferences; \n(c) the risks associated with the use of the device when it comes into contact with mate rials, liquids, and \nsubstances, including gases, to which it is exposed during normal conditions of use; \n(d) the risks associated with the possible negative inter action between software and the IT environment within \nwhich it operat es and interacts; \n(e) the risks of accidental ingress of substances into the device; \n(f) the risks of reciprocal interfe rence with other devices normally used in the investigat ions or for the \ntreatment given; and \n(g) risks arising where maintenance or calibration are not possible (as with implants), from ageing of mat erials \nused or loss of accuracy of any measur ing or control mechanism. \n14.3. Devices shall be designed and manufactured in such a way as to minimise the risks of fire or explosion during \nnormal use and in sing le fault condition. Particular attention shall be paid to devices the intende d use of whic h \nincludes exposure to or use in association with flammable or explosive substances or substances whic h could \ncause combustion. \n14.4. Devices shall be designed and manuf actured in such a way that adjustment, calibration, and maintenance can \nbe done safely and effectively . \n14.5. Devices that are intended to be operat ed together with other devices or products shall be designed and \nmanufactured in such a way that the interoperability and compati bility are reliable and safe. \n14.6 Any measurement, monitoring or displa y scale shall be designed and manufactured in line with ergonomic \nprinciples, taking account of the intended purpose, users and the envi ronmental conditions in whic h the \ndevices are intende d to be used. \n14.7. Devices shall be designed and manufa ctured in such a way as to facilitate their safe disposal and the safe \ndisposal of related waste substances by the user , patient or other person. To that end, manufacturers shall \nidentify and test procedures and measures as a result of which their devices can be safely disposed after use. \nSuch procedures shall be descr ibed in the instr uctions for use. \n15. Devices with a diagnostic or measur ing function \n15.1. Diagnostic devices and devices with a measur ing function, shall be designed and manufactured in such a way as \nto provide suffi cient accuracy , precision and stability for their intende d purpose, based on appropr iate scientifi c \nand technical methods. The limits of accuracy shall be indicated by the manuf acturer . \n15.2. The measurements made by devices with a measur ing function shall be expressed in legal units conf orming to \nthe provisions of Council Directive 80/181/EEC (1). 5.5.2017 L 117/99 Official Jour nal of the European Union EN \n(1)Council Directive 80/181/EEC of 20 December 1979 on the appro ximation of the laws of the Member States relating to units of \nmeasurement and on the repeal of Directive 71/354/EEC (OJ L 39, 15.2.1980, p. 40). \n 16. Protection against radiation \n16.1. General \n(a) Devices shall be designed, manuf actured and packag ed in such a way that exposure of patients, users and \nother persons to radiation is reduced as far as possible, and in a manner that is compatible with the \nintended purpose, whilst not restr icting the application of appropr iate specifi ed levels for therapeutic and \ndiagnostic purposes. \n(b) The operating instr uctions for devices emitting hazardous or poten tially hazardous radiation shall contain \ndetailed information as to the nature of the emitted radiation, the means of prot ecting the patient and the \nuser , and on ways of avoiding misuse and of reducing the risks inherent to installation as far as possible \nand appropr iate. Information regar ding the acceptance and performa nce testin g, the acceptance criteria, and \nthe maintenance procedure shall also be specifi ed. \n16.2. Intended radiation \n(a) Where devices are designed to emit hazardous, or poten tially hazardous, levels of ionizing and/or non- \nionizing radiation necessar y for a specific medical purpose the benefi t of which is considered to outweigh \nthe risks inherent to the emission, it shall be possible for the user to control the emissions. Such devices \nshall be designed and manufa ctured to ensure reproducibility of relevant variable parameters within an \nacceptable tolerance. \n(b) Where devices are intended to emit hazardous, or poten tially hazardous, ionizing and/or non-ionizing \nradiation, they shall be fitted, where possible, with visual displa ys and/or audible warnings of such \nemissions. \n16.3. Devices shall be designed and manuf actured in such a way that exposure of patients, users and other persons to \nthe emission of unintend ed, stray or scattered radiation is reduced as far as possible. Where possible and \nappropr iate, methods shall be selecte d whic h reduce the exposure to radiation of patients, users and other \npersons who may be affected. \n16.4. Ionising radiation \n(a) Devices intended to emit ionizing radiation shall be designed and manuf actured taking into account the \nrequirements of the Directive 2013/59/Euratom laying down basic safety standards for protect ion against \nthe dangers arising from exposure to ionising radiation. \n(b) Devices intended to emit ionising radiation shall be designed and manufactured in such a way as to ensure \nthat, where possible, taking into account the intended use, the quantity , geometr y and quality of the \nradiation emitt ed can be varied and controlled, and, if possible, monitor ed during treatment. \n(c) Devices emitting ionising radiation intended for diagnostic radiology shall be designed and manufactured in \nsuch a way as to achi eve an image and/or output quality that are appropr iate to the intended medical \npurpose whilst minimising radiation exposure of the patient and user . \n(d) Devices that emit ionising radiation and are intended for therapeutic radiology shall be designed and \nmanufactured in such a way as to enable reliable monitori ng and control of the delivered dose, the beam \ntype, energy and, where appropr iate, the quality of radiation. \n17. Electronic programmable systems — devices that incor porate electronic programmable systems and software \nthat are devices in themselves \n17.1. Devices that incor porate electronic programmable systems, including software, or software that are devices in \nthemselves, shall be designed to ensure repeatability , reliability and performa nce in line with their intended use. \nIn the event of a sing le fault condition, appropr iate means shall be adopt ed to eliminate or reduce as far as \npossible consequent risks or imp airment of performa nce. \n17.2. For devices that incor porat e software or for software that are devices in themselves, the software shall be \ndeveloped and manuf actured in accordance with the state of the art taking into account the principles of \ndevelopment life cycle, risk manag ement, including information secur ity, verification and validation. 5.5.2017 L 117/100 Official Jour nal of the European Union EN \n 17.3. Software refer red to in this Section that is intended to be used in combination with mobile computing \nplatf orms shall be designed and manufactured taking into account the specific features of the mobile platf orm \n(e.g. size and contrast ratio of the screen) and the extern al factors related to their use (var ying environment as \nregards level of light or noise). \n17.4. Manufactur ers shall set out minimum requirements concer ning hardware, IT netw orks character istics and IT \nsecur ity measures, including protection against unauthor ised access, necessar y to run the software as intended. \n18. Active devices and devices connected to them \n18.1. For non-implantable active devices, in the event of a sing le fault condition, appropr iate means shall be adopt ed \nto eliminate or reduce as far as possible consequent risks. \n18.2. Devices where the safety of the patient depends on an intern al power supply shall be equipped with a means of \ndeter mining the state of the power supply and an appropr iate warning or indication for when the capacity of \nthe power supply becomes critical. If necessar y, such warning or indication shall be given prior to the power \nsupply becoming critical. \n18.3. Devices where the safety of the patient depends on an extern al power supply shall include an alarm system to \nsignal any power failure. \n18.4. Devices intended to monitor one or more clinical parameter s of a patient shall be equipped with appropr iate \nalarm systems to alert the user of situations which could lead to death or severe deterioration of the patient's \nstate of health. \n18.5. Devices shall be designed and manufa ctured in such a way as to reduce as far as possible the risks of creating \nelectromagnetic interference which could impair the operation of the device in question or other devices or \nequipment in the intended envi ronment. \n18.6. Devices shall be designed and manuf actured in such a way as to provide a level of intrinsic immunity to electro \nmagnetic interference such that is adequate to enable them to operat e as intended. \n18.7. Devices shall be designed and manuf actured in such a way as to avoid, as far as possible, the risk of accidental \nelectr ic shocks to the patient, user or any other person, both during normal use of the device and in the event \nof a sing le fault condition in the device, provided the device is installed and maintained as indicated by the \nmanufacturer . \n18.8. Devices shall be designed and manuf actured in such a way as to prot ect, as far as possible, against unauthor ised \naccess that could hamper the device from functioning as intended. \n19. Particular requirements for active implantable devices \n19.1. Active implantable devices shall be designed and manufactured in such a way as to remo ve or minimize as far \nas possible: \n(a) risks connected with the use of energy sources with particular reference, where electr icity is used, to \ninsulation, leakage currents and overheating of the devices, \n(b) risks connecte d with medical treatment, in particular those resulting from the use of defibr illators or high- \nfrequency surgical equipment, and \n(c) risks which may arise where mainte nance and calibration are impossible, including: \n— excessiv e increase of leakage currents, \n— ageing of the mater ials used, \n— excess heat generat ed by the device, \n— decreased accuracy of any measur ing or control mechanism. \n19.2. Active implantable devices shall be designed and manuf actured in such a way as to ensure \n— if applicable, the compatibility of the devices with the substances they are intended to administer , and \n— the reliability of the source of energy . 5.5.2017 L 117/101 Official Jour nal of the European Union EN \n 19.3. Active implantable devices and, if appropr iate, their compo nent parts shall be identif iable to allow any \nnecessar y measure to be taken following the disco very of a potential risk in connection with the devices or \ntheir component parts. \n19.4. Active implantable devices shall bear a code by whic h they and their manufa cturer can be unequivocally \nidentif ied (par ticularly with regard to the type of device and its year of manufacture); it shall be possible to read \nthis code, if necessar y, without the need for a surgical operation. \n20. Protection against mechanical and ther mal risks \n20.1. Devices shall be designed and manufa ctured in such a way as to protect patients and users again st mechanical \nrisks connected with, for exam ple, resistance to movement, instability and moving parts. \n20.2. Devices shall be designed and manufactured in such a way as to reduce to the lowest possible level the risks \narising from vibration generat ed by the devices, taking account of technical progress and of the means available \nfor limiting vibrations, particularly at source, unless the vibrations are part of the specifi ed performa nce. \n20.3. Devices shall be designed and manufactured in such a way as to reduce to the lowest possible level the risks \narising from the noise emitted , taking account of technical progress and of the means available to reduce noise, \nparticularly at source, unless the noise emitted is part of the specified performa nce. \n20.4. Terminals and connectors to the electr icity , gas or hydraulic and pneumatic energy supplies which the user or \nother person has to handle, shall be designed and constr ucted in such a way as to minimise all possible risks. \n20.5. Errors likely to be made when fitting or refitting certain parts which could be a source of risk shall be made \nimpossible by the design and constr uction of such parts or, failing this, by information given on the parts \nthemselves and/or their housings. \nThe same information shall be given on moving parts and/or their housings where the direction of movement \nneeds to be kno wn in order to avoid a risk. \n20.6. Accessible parts of devices (excluding the parts or areas intended to supply heat or reach given temperatures) \nand their surroundings shall not attain poten tially dange rous temperatures under normal conditions of use. \n21. Protection against the risks posed to the patient or user by devices supplying energy or substances \n21.1. Devices for supplying the patient with energy or substances shall be designed and constr ucted in such a way \nthat the amount to be delivered can be set and maintained accurat ely enough to ensure the safety of the patient \nand of the user . \n21.2. Devices shall be fitted with the means of preventing and/or indicating any inadequacies in the amount of \nenergy delivered or substances delivered which could pose a dange r. Devices shall incor porat e suitable means to \nprevent, as far as possible, the accidental release of dang erous levels of energy or substances from an energy \nand/or substance source. \n21.3. The function of the controls and indicators shall be clearly specifi ed on the devices. Where a device bears \ninstr uctions required for its operation or indicates operating or adjustment parameter s by means of a visual \nsystem, such information shall be understandable to the user and, as appropr iate, the patient. \n22. Protection against the risks posed by medical devices intended by the manufa cturer for use by lay persons \n22.1. Devices for use by lay persons shall be designed and manuf actured in such a way that they perform \nappropr iately for their intended purpose taking into account the skills and the means available to lay persons \nand the influence resulting from variation that can be reasonably anticipated in the lay person's technique and \nenvi ronment. The information and instr uctions provided by the manufact urer shall be easy for the lay person \nto understand and apply . 5.5.2017 L 117/102 Official Jour nal of the European Union EN \n 22.2. Devices for use by lay persons shall be designed and manufactured in such a way as to: \n— ensure that the device can be used safely and accurat ely by the intended user at all stages of the procedure, \nif necessar y after appropr iate training and/or information, \n— reduce, as far as possible and appropr iate, the risk from unintend ed cuts and pricks such as needle stick \ninjur ies, and \n— reduce as far as possible the risk of error by the intended user in the handling of the device and, if \napplicable, in the interpr etation of the results. \n22.3. Devices for use by lay persons shall, where appropr iate, include a procedure by whic h the lay person: \n— can verify that, at the time of use, the device will perform as intended by the manuf acturer , and \n— if applicable, is warned if the device has failed to provide a valid result. \nCHAPTER III \nREQUIREMENTS REGARDING THE INFORMA TION SUPPLIED WITH THE DEVICE \n23. Label and instr uctions for use \n23.1. General requirements regarding the information supplied by the manuf acturer \nEach device shall be accompan ied by the information needed to identify the device and its manuf acturer , and \nby any safety and perf ormance information relevant to the user , or any other person, as appropr iate. Such \ninformation may appear on the device itself, on the packag ing or in the instr uctions for use, and shall, if the \nmanufacturer has a website, be made available and kept up to date on the website, taking into account the \nfollowing: \n(a) The medium, format, content, legibility , and location of the label and instr uctions for use shall be \nappropr iate to the particular device, its intende d purpose and the technical knowledge, exper ience, \neducation or training of the intended user(s). In particular , instr uctions for use shall be written in term s \nreadily underst ood by the intended user and, where appropr iate, supplemented with drawings and \ndiagrams. \n(b) The information required on the label shall be provided on the device itself. If this is not practicable or \nappropr iate, some or all of the information may appear on the packag ing for each unit, and/or on the \npackaging of multiple devices. \n(c) Labels shall be provided in a human-readable format and may be supplement ed by mach ine-readable \ninformation, such as radio-frequency identification (‘RFID’) or bar codes. \n(d) Instr uctions for use shall be provided together with devices. By way of excep tion, instr uctions for use shall \nnot be required for class I and class IIa devices if such devices can be used safely without any such \ninstr uctions and unless other wise provided for elsewhere in this Section. \n(e) Where multiple devices are supplied to a sing le user and/or location, a sing le copy of the instr uctions for \nuse may be provided if so agreed by the purc haser who in any case may request further copies to be \nprovided free of charg e. \n(f) Instr uctions for use may be provided to the user in non-paper format (e.g. electronic) to the extent, and \nonly under the conditions, set out in Regulation (EU) No 207/2012 or in any subsequent implementing \nrules adopt ed pursuant to this Regulation. \n(g) Residual risks which are required to be communicated to the user and/or other person shall be included as \nlimitations, contra-indications, precautions or warnings in the information supplied by the manufacturer . \n(h) Where appropr iate, the information supplied by the manufacturer shall take the form of intern ationally \nrecognised symbols. Any symbol or identification colour used shall conf orm to the harmonised standards \nor CS. In areas for which no harmonised standards or CS exist, the symbols and colours shall be descr ibed \nin the documentation supplied with the device. 5.5.2017 L 117/103 Official Jour nal of the European Union EN \n 23.2. Information on the label \nThe label shall bear all of the following particulars: \n(a) the name or trade name of the device; \n(b) the details strictly necessar y for a user to identify the device, the conte nts of the packag ing and, where it is \nnot obvious for the user , the intended purpose of the device; \n(c) the name, registere d trade name or register ed trade mark of the manufacturer and the address of its \nregistered place of business; \n(d) if the manufact urer has its registere d place of business outside the Union, the name of the author ised rep\nresentative and address of the registere d place of business of the author ised representative; \n(e) where applicable, an indication that the device contains or incor porat es: \n— a medicinal substance, including a human blood or plasma derivative, or \n— tissues or cells, or their derivatives, of human origin, or \n— tissues or cells of animal origin, or their derivatives, as refer red to in Regulation (EU) No 722/2012; \n(f) where applicable, information labelled in accordance with Section 10.4.5.; \n(g) the lot number or the serial number of the device preceded by the words LOT NUMBER or SERIAL \nNUMBER or an equivalent symbol, as appropr iate; \n(h) the UDI carrier referred to in Article 27(4) and Part C of Annex VII; \n(i) an unambiguous indication of t the time limit for using or implanting the device safely , expressed at least \nin term s of year and month, where this is relevant ; \n(j) where there is no indication of the date until when it may be used safely , the date of manuf acture. This \ndate of manufa cture may be included as part of the lot number or serial number , provided the date is \nclearly identif iable; \n(k) an indication of any special storag e and/or handling condition that applies; \n(l) if the device is supplied sterile, an indication of its steril e state and the sterilis ation method; \n(m) warnings or precautions to be taken that need to be brought to the immediate attenti on of the user of the \ndevice, and to any other person. This information may be kept to a minimum in which case more detailed \ninformation shall appear in the instr uctions for use, taking into account the intended users; \n(n) if the device is intende d for sing le use, an indication of that fact. A manufacturer's indication of sing le use \nshall be consistent across the Union; \n(o) if the device is a sing le-use device that has been reprocessed, an indication of that fact, the number of \nreprocessing cycles already performed, and any limitation as regards the number of reprocessing cycles; \n(p) if the device is custom-made, the words ‘custom-made device’; \n(q) an indication that the device is a medical device. If the device is intended for clinical investigat ion only , the \nwords ‘exclusively for clinical investigation’; \n(r) in the case of devices that are compo sed of substances or of combinations of substances that are intended \nto be introduced into the human body via a body orifice or applied to the skin and that are absorbed by \nor locally dispersed in the human body , the overall qualitative compo sition of the device and quantitative \ninformation on the main constituent or constituents responsible for achi eving the principal intende d \naction; \n(s) for active implantable devices, the serial number , and for other implantable devices, the serial number or \nthe lot number . \n23.3. Information on the packag ing which maintains the steri le condition of a device (‘sterile packag ing’) \nThe following particulars shall appear on the sterile packag ing: \n(a) an indication permitting the steri le packag ing to be recognised as such, \n(b) a declaration that the device is in a steril e condition, 5.5.2017 L 117/104 Official Jour nal of the European Union EN \n (c) the method of steril isation, \n(d) the name and address of the manuf acturer , \n(e) a descr iption of the device, \n(f) if the device is intended for clinical inve stigations, the words ‘exclusively for clinical investigations’, \n(g) if the device is custom-made, the words ‘custom-made device’, \n(h) the month and year of manuf acture, \n(i) an unambiguous indication of the time limit for using or implanting the device safely expressed at least in \nterm s of year and month, and \n(j) an instr uction to check the instr uctions for use for what to do if the steril e packaging is damage d or \nunintentionally opened before use. \n23.4. Information in the instr uctions for use \nThe instr uctions for use shall contain all of the following particulars: \n(a) the particulars referred to in points (a), (c), (e), (f), (k), (l), (n) and (r) of Section 23.2; \n(b) the device's intended purpose with a clear specifi cation of indications, contra-indications, the patient target \ngroup or groups, and of the intended users, as appropr iate; \n(c) where applicable, a specifi cation of the clinical benefits to be expecte d. \n(d) where applicable, links to the summar y of safety and clinical performa nce refer red to in Article 32; \n(e) the performa nce character istics of the device; \n(f) where applicable, information allowing the healthcare profes sional to verify if the device is suitable and \nselect the corresponding software and accessor ies; \n(g) any residual risks, contra-indications and any undesirable side-effects, including information to be \nconve yed to the patient in this regar d; \n(h) specifi cations the user requires to use the device appropr iatel y, e.g. if the device has a measur ing function, \nthe degree of accuracy claimed for it; \n(i) details of any preparatory treatment or handling of the device before it is ready for use or during its use, \nsuch as sterilis ation, final assembly , calibration, etc., including the levels of disinf ection required to ensure \npatient safety and all available methods for achieving those levels of disinf ection; \n(j) any requirements for special facilities, or special training, or particular qualifications of the device user \nand/or other persons; \n(k) the information needed to verify whether the device is properly installed and is ready to perform safely \nand as intended by the manuf acturer , together with, where relevant: \n— details of the nature, and frequency , of preventive and regular mainte nance, and of any preparat ory \ncleaning or disinf ection, \n— identif ication of any consumable compo nents and how to replace them, \n— information on any necessar y calibration to ensure that the device operat es properly and safely during \nits intende d lifetime, and \n— methods for eliminating the risks encount ered by persons involved in installing, calibrating or \nservicing devices; \n(l) if the device is supplied steri le, instr uctions in the event of the sterile packag ing being damaged or \nunintentionally opened before use; 5.5.2017 L 117/105 Official Jour nal of the European Union EN \n (m) if the device is supplied non-steri le with the intention that it is sterilised before use, the appropr iate \ninstr uctions for sterilisation; \n(n) if the device is reusable, information on the appropr iate processes for allowing reuse, including cleaning, \ndisinfection, packa ging and, where appropr iate, the validat ed method of re-st erilisation appropr iate to the \nMember State or Member State s in which the device has been placed on the market. Information shall be \nprovided to identify when the device should no long er be reused, e.g. signs of mate rial degradation or the \nmaximum number of allowable reuses; \n(o) an indication, if appropr iate, that a device can be reused only if it is reconditioned under the responsibility \nof the manufacturer to compl y with the general safety and perf ormance requirements; \n(p) if the device bears an indication that it is for sing le use, information on kno wn character istics and \ntechnical factors kno wn to the manufa cturer that could pose a risk if the device were to be re-used. This \ninformation shall be based on a specifi c section of the manuf acturer's risk manage ment documentation, \nwhere such charact eristics and technical factors shall be addressed in detail. If in accordance with point (d) \nof Section 23.1. no instr uctions for use are required, this information shall be made available to the user \nupon request ; \n(q) for devices intended for use together with other devices and/or general purpose equipment: \n— information to identify such devices or equipment, in order to obtain a safe combination, and/or \n— information on any kno wn restr ictions to combinations of devices and equipment ; \n(r) if the device emits radiation for medical purposes: \n— detailed information as to the nature, type and where appropr iate, the intensity and distr ibution of the \nemitted radiation, \n— the means of protecting the patient, user , or other person from unint ended radiation during use of the \ndevice; \n(s) information that allows the user and/or patient to be informed of any warnings, precautions, contra- \nindications, measures to be take n and limitations of use regarding the device. That information shall, \nwhere relevant, allow the user to brief the patient about any warnings, precautions, contra-indications, \nmeasures to be take n and limitations of use regarding the device. The information shall cover, where \nappropr iate: \n— warnings, precautions and/or measures to be taken in the event of malfunction of the device or \nchanges in its performa nce that may affect safety , \n— warnings, precautions and/or measures to be taken as regards the exposure to reasonably foreseeable \nexternal influences or environmental conditions, such as magnetic fields, extern al electr ical and electro \nmagnetic effects, electrostatic disc harge, radiation associated with diagnostic or therapeutic procedures, \npressure, humidity , or temperature, \n— warnings, precautions and/or measures to be taken as regar ds the risks of interference posed by the \nreasonably foreseeable presence of the device during specific diagnostic investig ations, evaluations, or \ntherapeutic treatment or other procedures such as electromagnetic interference emitt ed by the device \naffecting other equipment, \n— if the device is intended to administe r medicinal products, tissues or cells of human or animal origin, \nor their derivatives, or biological substances, any limitations or incompati bility in the choice of \nsubstances to be delivered, \n— warnings, precautions and/or limitations related to the medicinal substance or biological mater ial that \nis incor porated into the device as an integral part of the device; and \n— precautions related to mater ials incor porat ed into the device that contain or consist of CMR substances \nor endocr ine-disr upti ng substances, or that could result in sensitisation or an allergic reaction by the \npatient or user; 5.5.2017 L 117/106 Official Jour nal of the European Union EN \n (t) in the case of devices that are compo sed of substances or of combinations of substances that are intended \nto be introduced into the human body and that are absorbed by or locally dispersed in the human body , \nwarnings and precautions, where appropr iate, relat ed to the general profile of interaction of the device and \nits products of metabolism with other devices, medicinal products and other substances as well as contra- \nindications, undesirable side-eff ects and risks relating to overdose; \n(u) in the case of implantable devices, the overall qualitative and quantitative information on the mater ials and \nsubstances to whic h patients can be exposed; \n(v) warnings or precautions to be taken in order to facilitat e the safe disposal of the device, its accessor ies and \nthe consumables used with it, if any. This information shall cover, where appropr iate: \n— infection or microbial hazards such as explants, needles or surgical equipment contaminated with \npoten tially infectious substances of human origin, and \n— physical hazards such as from shar ps. \nIf in accordance with the point (d) of Section 23.1 no instr uctions for use are required, this information \nshall be made available to the user upon request ; \n(w) for devices intended for use by lay persons, the circumstances in which the user should consult \na healthcare professional; \n(x) for the devices covered by this Regulation pursuant to Article 1(2), information regar ding the absence of \na clinical benefi t and the risks relat ed to use of the device; \n(y) date of issue of the instr uctions for use or, if they have been revised, date of issue and identifier of the \nlatest revision of the instr uctions for use; \n(z) a notice to the user and/or patient that any serious incident that has occur red in relation to the device \nshould be repor ted to the manufacturer and the compe tent author ity of the Member State in whic h the \nuser and/or patient is established; \n(aa) information to be supplied to the patient with an implant ed device in accordance with Article 18; \n(ab) for devices that incor porat e electronic programmable systems, including software, or software that are \ndevices in themselves, minimum requirements concer ning hardware, IT netw orks charact eristics and IT \nsecur ity measures, including protection against unauthor ised access, necessar y to run the software as \nintended. 5.5.2017 L 117/107 Official Jour nal of the European Union EN \n ANNEX II \nTECHNIC AL DOCUMENT ATION \nThe technical documentation and, if applicable, the summar y thereof to be drawn up by the manuf acturer shall be \npresent ed in a clear , organised, readily searc hable and unambiguous manner and shall include in particular the elements \nlisted in this Annex. \n1. DEVICE DESCRIPTION AND SPECIFIC ATION, INCLUDING VARIANTS AND ACCESSORIES \n1.1. Device descr iption and specification \n(a) product or trade name and a general descr iption of the device including its intended purpose and intended \nusers; \n(b) the Basic UDI-DI as referred to in Part C of Annex VI assigned by the manufacturer to the device in question, \nas soon as identif ication of this device becomes based on a UDI system, or other wise a clear identification by \nmeans of product code, catalogue number or other unambiguous reference allowing traceability ; \n(c) the intended patient population and medical conditions to be diagnosed, treated and/or monit ored and other \nconsiderations such as patient selection criteria, indications, contra-indications, warnings; \n(d) principles of operation of the device and its mode of action, scientifi cally demonstrated if necessar y; \n(e) the rationale for the qualifi cation of the product as a device; \n(f) the risk class of the device and the justif ication for the classificat ion rule(s) applied in accordance with \nAnnex VIII; \n(g) an explanation of any novel features; \n(h) a descr iption of the accessor ies for a device, other devices and other products that are not devices, whic h are \nintended to be used in combination with it; \n(i) a descr iption or compl ete list of the various configurations/var iants of the device that are intended to be made \navailable on the mark et; \n(j) a general descr iption of the key functional elements, e.g. its parts/componen ts (including software if \nappropr iate), its formulation, its composition, its functionality and, where relevant, its qualitative and \nquantitative compo sition. Where appropr iate, this shall include labelled pictorial representations (e.g. diagrams, \nphotog raphs, and drawings), clearly indicating key parts/componen ts, including suffi cient explanation to \nunderstand the drawings and diagrams; \n(k) a descr iption of the raw mater ials incor porate d into key functional elements and those making either direct \ncontact with the human body or indirect contact with the body , e.g., during extracor poreal circulation of body \nfluids; \n(l) technical specific ations, such as features, dimensions and performa nce attributes, of the device and any \nvariants/configur ations and accessor ies that would typically appear in the product specif ication made available \nto the user , for exam ple in broch ures, catalogues and similar publications. \n1.2. Reference to previous and similar generations of the device \n(a) an overview of the previous generation or generations of the device produced by the manufa cturer , where such \ndevices exist ; \n(b) an overview of identified similar devices available on the Union or internati onal markets, where such devices \nexist. \n2. INFORMA TION TO BE SUPPLIED BY THE MANUF ACTURER \nA complet e set of: \n— the label or labels on the device and on its packag ing, such as sing le unit packag ing, sales packaging, transpor t \npackaging in case of specifi c manage ment conditions, in the language s accept ed in the Member State s where the \ndevice is envi saged to be sold; and 5.5.2017 L 117/108 Official Jour nal of the European Union EN \n — the instr uctions for use in the languag es accept ed in the Member State s where the device is envisaged to be \nsold. \n3. DESIGN AND MANUF ACTURING INFORMA TION \n(a) information to allow the design stages applied to the device to be understood; \n(b) compl ete information and specifi cations, including the manuf actur ing processes and their validation, their \nadjuvants, the continuous monitoring and the final product testing. Data shall be fully included in the technical \ndocumentation; \n(c) identification of all sites, including suppliers and sub-contractor s, where design and manufactur ing activities are \nperformed. \n4. GENERAL SAFET Y AND PERFORMANCE REQUIREMENTS \nThe documentation shall contain information for the demonstration of conf ormity with the general safety and \nperf ormance requirements set out in Annex I that are applicable to the device taking into account its intended \npurpose, and shall include a justification, validation and verification of the solutions adopt ed to meet those \nrequirements. The demonstration of conf ormity shall include: \n(a) the general safety and perf ormance requirements that apply to the device and an explanation as to why others \ndo not apply ; \n(b) the method or methods used to demonstrate conf ormity with each applicable general safety and performance \nrequirement ; \n(c) the harmonised standards, CS or other solutions applied; and \n(d) the precise identity of the controlled documents offer ing evidence of conf ormity with each harmonised \nstandard, CS or other method applied to demonstrate conf ormity with the general safet y and performance \nrequirements. The information refer red to under this point shall incor porate a cross-reference to the location of \nsuch evidence within the full technical documentation and, if applicable, the summar y technical documentation. \n5. BENEFIT -RISK ANAL YSIS AND RISK MANA GEMENT \nThe documentation shall contain information on: \n(a) the benefit-r isk analysis refer red to in Sections 1 and 8 of Annex I, and \n(b) the solutions adop ted and the results of the risk manage ment refer red to in Section 3 of Annex I. \n6. PRODUCT VERIFICA TION AND VALID ATION \nThe documentation shall contain the results and critical analyses of all verifications and validation tests and/or \nstudies under taken to demonstrate conf ormity of the device with the requirements of this Regulation and in \nparticular the applicable general safet y and performa nce requirements. \n6.1. Pre-clinical and clinical data \n(a) results of tests, such as engineer ing, laboratory , simulat ed use and animal tests, and evaluation of published \nliterature applicable to the device, taking into account its intende d purpose, or to similar devices, regarding the \npre-clinical safety of the device and its conf ormity with the specifi cations; \n(b) detailed information regar ding test design, compl ete test or study protocols, methods of data analysis, in \naddition to data summar ies and test conclusions regar ding in particular: \n— the biocompat ibility of the device including the identif ication of all mater ials in direct or indirect contact \nwith the patient or user; \n— physical, chemical and microbiological character isation; \n— electr ical safet y and electromagnetic compati bility ; 5.5.2017 L 117/109 Official Jour nal of the European Union EN \n — software verification and validation (descr ibing the software design and development process and evidence \nof the validation of the software, as used in the finished device. This information shall typically include the \nsummar y results of all verification, validation and testing perf ormed both in-house and in a simulat ed or \nactual user environment prior to final release. It shall also address all of the diffe rent hardware conf ig\nurations and, where applicable, operating syste ms identified in the information supplied by the \nmanuf acturer); \n— stability , including shelf life; and \n— perf ormance and safety . \nWhere applicable, conf ormity with the provisions of Directive 2004/10/EC of the European Parliament and of \nthe Council (1) shall be demonstrate d. \nWhere no new testing has been under taken, the documentation shall incor porat e a rationale for that decision. \nAn examp le of such a rationale would be that biocompatibility testing on identical mater ials was conducted \nwhen those mat erials were incor porated in a previous version of the device that has been legally placed on the \nmark et or put into service; \n(c) the clinical evaluation repor t and its update s and the clinical evaluation plan referred to in Article 61(12) and \nPart A of Annex XIV; \n(d) the PMCF plan and PMCF evaluation repor t refer red to in Part B of Annex XIV or a justification why a PMCF is \nnot applicable. \n6.2. Additional information required in specific cases \n(a) Where a device incor porates, as an integral part, a substance which , if used separately , may be considered to be \na medicinal product within the meaning of point 2 of Article 1 of Directive 2001/83/EC, including a medicinal \nproduct derived from human blood or human plasma, as refer red to in the first subparagraph of Article 1(8), \na statement indicating this fact. In this case, the documentation shall identify the source of that substance and \ncontain the data of the tests conduct ed to assess its safety , quality and usefulness, taking account of the \nintende d purpose of the device. \n(b) Where a device is manufactured utilising tissues or cells of human or animal origin, or their derivatives, and is \ncovered by this Regulation in accordance with points (f) and (g) of Article 1(6, and where a device incor porate s, \nas an integral part, tissues or cells of human origin or their derivatives that have an action ancillar y to that of \nthe device and is covered by this Regulation in accordance with the first subparagraph of Article 1(10), \na state ment indicating this fact. In such a case, the documentation shall identify all mater ials of human or \nanimal origin used and provide detailed information concer ning the conf ormity with Sections 13.1. or 13.2., \nrespectively , of Annex I. \n(c) In the case of devices that are compo sed of substances or combinations of substances that are intended to be \nintroduced into the human body and that are absorbed by or locally dispersed in the human body , detailed \ninformation, including test design, complet e test or study protocols, methods of data analysis, and data \nsummar ies and test conclusions, regarding studies in relation to: \n— absor ption, distr ibution, metabolism and excretion; \n— possible inter actions of those substances, or of their products of metabolism in the human body , with other \ndevices, medicinal products or other substances, consider ing the target population, and its associated \nmedical conditions; \n— local tolerance; and \n— toxicity , including sing le-dose toxicity , repeat-dose toxicity , genoto xicity , carcinog enicity and reproductive \nand developmental toxicity , as applicable depending on the level and nature of exposure to the device. \nIn the absence of such studies, a justification shall be provided. \n(d) In the case of devices containing CMR or endocr ine-disr upting substances refer red to in Section 10.4.1 of \nAnnex I, the justification refer red to in Section 10.4.2 of that Annex. 5.5.2017 L 117/110 Official Jour nal of the European Union EN \n(1)Directive 2004/10/EC of the European Parliament and of the Council of 11 Febr uary 2004 on the harmonisation of laws, regulations \nand administrative provisions relating to the application of the principles of good laboratory practice and the verification of their \napplications for tests on chemical substances (OJ L 50, 20.2.2004, p. 44). \n (e) In the case of devices placed on the mark et in a steri le or defined microbiological condition, a descr iption of \nthe environmental conditions for the relevant manufactur ing step s. In the case of devices placed on the mark et \nin a steri le condition, a descr iption of the methods used, including the validation repor ts, with respect to \npackag ing, steri lisation and maintenanc e of sterilit y. The validation repor t shall address bioburden testing, \npyrogen testing and, if applicable, testing for steri lant residues. \n(f) In the case of devices placed on the mark et with a measur ing function, a descr iption of the methods used in \norder to ensure the accuracy as given in the specifi cations. \n(g) If the device is to be connecte d to other device(s) in order to operat e as intended, a descr iption of this \ncombination/configuration including proof that it conf orms to the general safety and performa nce \nrequirements when connected to any such device(s) having regar d to the charact eristics specified by the \nmanuf acturer . 5.5.2017 L 117/111 Official Jour nal of the European Union EN \n ANNEX III \nTEC HNIC AL DOCUMENT ATION ON POST -MARKET SUR VEILL ANCE \nThe technical documentation on post-market surveillance to be drawn up by the manuf acturer in accordance with \nArticles 83 to 86 shall be present ed in a clear , organised, readily searc hable and unambiguous manner and shall include \nin particular the elements descr ibed in this Annex. \n1.1. The post-market surveillance plan drawn up in accordance with Article 84. \nThe manufacturer shall prove in a post-market surveillance plan that it compl ies with the obligation referred to \nin Article 83. \n(a) The post-market surveillance plan shall address the collection and utilization of available information, in \nparticular: \n— information concer ning serious incidents, including information from PSURs, and field safety corrective \nactions; \n— records refer ring to non-ser ious incidents and data on any undesirable side-eff ects; \n— information from trend repor ting; \n— relevant specialist or technical literature, databases and/or register s; \n— information, including feedbacks and complaints, provided by users, distr ibut ors and impor ters; and \n— publicly available information about similar medical devices. \n(b) The post-market surveillance plan shall cover at least : \n— a proactive and syste matic process to collect any information refer red to in point (a). The process shall \nallow a correct charact erisation of the perf ormance of the devices and shall also allow a compari son to \nbe made between the device and similar products available on the market ; \n— effective and appropr iate methods and processes to assess the collected data; \n— suitable indicators and threshold values that shall be used in the continuous reassessment of the benefit- \nrisk analysis and of the risk managemen t as referred to in Section 3 of Annex I; \n— effective and appropr iate methods and tools to investig ate compl aints and analyse mark et-related \nexper ience collect ed in the field; \n— methods and protocols to manage the events subject to the trend repor t as provided for in Article 88, \nincluding the methods and prot ocols to be used to establish any statistically signif icant increase in the \nfrequency or sever ity of incidents as well as the obser vation period; \n— methods and protocols to communicate effectively with compet ent author ities, notifi ed bodies, economic \noperat ors and users; \n— reference to procedures to fulfil the manuf acturers oblig ations laid down in Articles 83, 84 and 86; \n— system atic procedures to identify and initiate appropr iate measures including corrective actions; \n— effective tools to trace and identify devices for which corrective actions might be necessar y; and \n— a PMCF plan as refer red to in Part B of Annex XIV, or a justif ication as to why a PMCF is not applicable. \n1.2. The PSUR refer red to in Article 86 and the post-market surveillance repor t refer red to in Article 85. 5.5.2017 L 117/112 Official Jour nal of the European Union EN \n ANNEX IV \nEU DECL ARA TION OF CONFORMIT Y \nThe EU declaration of conf ormity shall contain all of the following information: \n1. Name, register ed trade name or registere d trade mark and, if already issued, SRN as referred to in Article 31 of the \nmanufa cturer , and, if applicable, its author ised representative, and the address of their registered place of business \nwhere they can be contacted and their location be established; \n2. A state ment that the EU declaration of conf ormity is issued under the sole responsibility of the manuf acturer ; \n3. The Basic UDI-DI as refer red to in Part C of Annex VI; \n4. Product and trade name, product code, catalogue number or other unambiguous reference allowing identif ication \nand traceability of the device covered by the EU declaration of conf ormity , such as a photograph, where \nappropr iate, as well as its intende d purpose. Except for the product or trade name, the information allowing identif i\ncation and traceability may be provided by the Basic UDI-DI refer red to in point 3; \n5. Risk class of the device in accordance with the rules set out in Annex VIII; \n6. A state ment that the device that is covered by the present declaration is in conf ormity with this Regulation and, if \napplicable, with any other relevant Union legislation that provides for the issuing of an EU declaration of \nconf ormity ; \n7. References to any CS used and in relation to whic h conf ormity is declared; \n8. Where applicable, the name and identif ication number of the notified body , a descr iption of the conf ormity \nassessment procedure performed and identif ication of the certificate or certificates issued; \n9. Where applicable, additional information; \n10. Place and date of issue of the declaration, name and function of the person who signed it as well as an indication \nfor, and on behalf of whom, that person signed, signature. 5.5.2017 L 117/113 Official Jour nal of the European Union EN \n ANNEX V \nCE MARKING OF CONFORMIT Y \n1. The CE marking shall consist of the initials ‘CE’ taking the following form: \n2. If the CE marking is reduced or enlarg ed, the propor tions given in the above graduat ed drawing shall be respected . \n3. The various components of the CE marking shall have substantially the same vertical dimension, whic h may not be \nless than 5 mm. This minimum dimension may be waived for small-scale devices. 5.5.2017 L 117/114 Official Jour nal of the European Union EN \n ANNEX VI \nINFOR MA TION TO BE SUBMITTED UPON THE REGISTRA TION OF DEVICES AND ECO NOMIC \nOPERA TORS IN ACCORD ANCE WITH ARTICLES 29(4) AND 31, CORE DATA ELEMENTS TO BE PROVIDED \nTO THE UDI DATABASE TOGETHER WITH THE UDI-DI IN ACCORD ANCE WITH ART ICLES 28 AND 29, \nAND THE UDI SYSTEM \nPART A \nINFOR MA TION TO BE SUBMITTED UPON THE REGISTRA TION OF DEVICES AND ECO NOMIC \nOPERA TORS IN ACCORD ANCE WITH ARTICLES 29(4) AND 31 \nManufactur ers or, when applicable, author ised representatives, and, when applicable, impor ters shall submit the \ninformation refer red to in Section 1 and shall ensure that the information on their devices referred to in Section 2 is \ncompl ete, correct and updated by the relevant party. \n1. Information relating to the economic operat or \n1.1. type of economic operat or(manuf acturer , author ised representative, or impor ter), \n1.2. name, address and contact details of the economic operat or, \n1.3. where submission of information is carried out by another person on behalf of any of the economic operat ors \nmentioned under Section 1.1, the name, address and contact details of that person, \n1.4. name address and contact details of the person or persons responsible for regulatory compl iance refer red to in"
},
"Article 6": null,
"Article 60": {
"heading": "Certificate of free sale",
"text": "Article 60 \nCer tificate of free sale \n1. For the purpose of expor t and upon request by a manufacturer or an author ised representative, the Member State \nin whic h the manufa cturer or the author ised representative has its register ed place of business shall issue a certificate of \nfree sale declar ing that the manufacturer or the author ised representative, as applicable, has its register ed place of \nbusiness on its territory and that the device in question bear ing the CE marking in accordance with this Regulation may \nbe market ed in the Union. The certificate of free sale shall set out the Basic UDI-DI of the device as provided to the \nUDI database under Article 29. Where a notifi ed body has issued a certificate pursuant to Article 56, the certificate of \nfree sale shall set out the unique number identifying the certificate issued by the notified body , as referred to in \nSection 3 of Chapt er II of Annex XII. \n2. The Commission may, by means of implemen ting acts, establish a model for certificates of free sale, taking into \naccount internati onal practice as regards the use of certificates of free sale. Those implementing acts shall be adop ted in \naccordance with the advisor y procedure refer red to in Article 114(2). \nCHAPTER VI \nCLINIC AL EVALU ATION AND CLINIC AL INVESTIGA TIONS"
},
"Article 61": null,
"Article 62": null,
"Article 63": null,
"Article 64": null,
"Article 65": null,
"Article 66": null,
"Article 67": null,
"Article 68": null,
"Article 69": null,
"Article 7": null,
"Article 70": null,
"Article 71": null,
"Article 72": null,
"Article 73": null,
"Article 74": null,
"Article 75": null,
"Article 76": null,
"Article 77": null,
"Article 78": null,
"Article 79": null,
"Article 8": null,
"Article 80": null,
"Article 81": null,
"Article 82": null,
"Article 83": null,
"Article 84": null,
"Article 85": null,
"Article 86": null,
"Article 87": null,
"Article 88": null,
"Article 89": null,
"Article 9": null,
"Article 90": null,
"Article 91": null,
"Article 92": null,
"Article 93": null,
"Article 94": null,
"Article 95": null,
"Article 96": null,
"Article 97": null,
"Article 98": null,
"Article 99": null
},
"title": "Classification and conformity assessment"
}
|
{
"text": "CE MARKING OF CONFORMIT Y \n1. The CE marking shall consist of the initials ‘CE’ taking the following form: \n2. If the CE marking is reduced or enlarg ed, the propor tions given in the above graduat ed drawing shall be respected . \n3. The various components of the CE marking shall have substantially the same vertical dimension, whic h may not be \nless than 5 mm. This minimum dimension may be waived for small-scale devices. 5.5.2017 L 117/114 Official Jour nal of the European Union EN",
"title": "ANNEX V"
}
|
{"articles":{"Article 1":null,"Article 10":null,"Article 100":null,"Article 101":null,"Article 102":(...TRUNCATED)
| {"text":"INFOR MA TION TO BE SUBMITTED UPON THE REGISTRA TION OF DEVICES AND ECO NOMIC \nOPERA TORS (...TRUNCATED)
|
{"articles":{"Article 1":null,"Article 10":null,"Article 100":{"heading":"Electronic system on marke(...TRUNCATED)
| {"text":"REQUIREMENTS TO BE MET BY NOTIFIED BODIES \n1. ORGANISA TIONAL AND GENERAL REQUIREMENTS \n(...TRUNCATED)
|
{"articles":{"Article 1":null,"Article 10":null,"Article 100":null,"Article 101":{"heading":"Compete(...TRUNCATED)
| {"text":"CLASSIFIC ATION RULES \nCHAPTER I \nDEFINITIONS SPECIFIC TO CLASSIFIC ATION RULES \n1. DUR(...TRUNCATED)
|
{"articles":{"Article 1":null,"Article 10":null,"Article 100":null,"Article 101":null,"Article 102":(...TRUNCATED)
| {"text":"CONFORMIT Y ASSESSMENT BASED ON A QUALIT Y MANA GEMENT SYSTEM AND ON ASSESSMENT OF \nTECHNI(...TRUNCATED)
|
{"articles":{"Article 1":null,"Article 10":null,"Article 100":null,"Article 101":null,"Article 102":(...TRUNCATED)
| {"text":"CONFORMIT Y ASSESSMENT BASED ON TYPE-EXAMINA TION \n1. EU type-examination is the procedur(...TRUNCATED)
|
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