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,
... | {
"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 a... |
{
"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,
"... | {
"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 DES... |
{
"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,
"... | {
"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 partic... |
{
"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,
"... | {
"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 t... |
{
"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,
"... | {
"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 t... |
{
"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,
"... | {
"text": "INFOR 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... |
{
"articles": {
"Article 1": null,
"Article 10": null,
"Article 100": {
"heading": "Electronic system on market surveillance",
"text": "Article 100 \nElectronic system on market surveillance \n1. The Commission, in collaboration with the Member State s, shall set up and manage an electronic sy... | {
"text": "REQUIREMENTS TO BE MET BY NOTIFIED BODIES \n1. ORGANISA TIONAL AND GENERAL REQUIREMENTS \n1.1. Legal status and organisational structure \n1.1.1. Each notified body shall be established under the national law of a Member State, or under the law of a third \ncountr y with whic h the Union has concluded a... |
{
"articles": {
"Article 1": null,
"Article 10": null,
"Article 100": null,
"Article 101": {
"heading": "Competent authorities",
"text": "Article 101 \nCompetent author ities \nThe Member States shall designat e the compet ent author ity or author ities responsible for the implementation o... | {
"text": "CLASSIFIC ATION RULES \nCHAPTER I \nDEFINITIONS SPECIFIC TO CLASSIFIC ATION RULES \n1. DURA TION OF USE \n1.1. ‘Transient’ means normally intende d for continuous use for less than 60 minutes. \n1.2. ‘Shor t term ’ means normally intended for continuous use for between 60 minutes and 30 days. \n1.3. ‘L... |
{
"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": {
"he... | {
"text": "CONFORMIT Y ASSESSMENT BASED ON A QUALIT Y MANA GEMENT SYSTEM AND ON ASSESSMENT OF \nTECHNIC AL DOCUMENT ATION \nCHAPTER I \nQUALIT Y MANA GEMENT SYSTEM \n1. The manufact urer shall establish, document and implemen t a quality manage ment system as descr ibed in \nArticle 10(9) and maintain its effectiven... |
{
"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,
"... | {
"text": "CONFORMIT Y ASSESSMENT BASED ON TYPE-EXAMINA TION \n1. EU type-examination is the procedure whereby a notified body ascer tains and certifies that a device, including its \ntechnical documentation and relevant life cycle processes and a corresponding representative sample of the device \nproduction envisa... |
null | {
"text": "CONFORM ITY ASSESSMENT BASED ON PRODUCT CONFORMIT Y VERIFIC ATION \n1. The objective of the conf ormity assessment based on product conf ormity verification is to ensure that devices \nconf orm to the type for whic h an EU type-examination certificate has been issued, and that they meet the \nprovisions o... |
null | {
"text": "CERT IFIC ATES ISSUED BY A NOTIFIED BOD Y \nCHAPTER I \nGENERAL REQUIREMENTS \n1. Certificates shall be drawn up in one of the official language s of the Union. \n2. Each certificate shall refer to only one conf ormity assessment procedure. \n3. Certificates shall only be issued to one manufacturer . Th... |
null | {
"text": "PROCEDURE FOR CUSTOM-MADE DEVICES \n1. For custom-made devices, the manufacturer or its author ised representative shall draw up a statement containing all \nof the following information: \n— the name and address of the manuf acturer , and of all manuf actur ing sites, \n— if applicable, the name and ad... |
null | {
"text": "CLINIC AL EVALU ATION AND POST -MARKET CLINIC AL FOLLO W-UP \nPART A \nCLINIC AL EVALU ATION \n1. To plan, continuously conduct and document a clinical evaluation, manuf acturers shall: \n(a) establish and update a clinical evaluation plan, which shall include at least: \n— an identif ication of the gen... |
null | {
"text": "CLINIC AL INVESTIGA TIONS \nCHAPTER I \nGENERAL REQUIREMENTS \n1. Ethical principles \nEach step in the clinical investigat ion, from the initial consideration of the need for and justification of the study \nto the publication of the results, shall be carried out in accordance with recognised ethical pri... |
null | {
"text": "LIST OF GROUPS OF PRODUCTS WITHOUT AN INTENDED MEDIC AL PURPOSE REFERRED TO IN \nART ICLE 1(2) \n1. Contact lenses or other items intended to be introduced into or onto the eye. \n2. Products intende d to be tota lly or partially introduced into the human body through surgically invasive means for \nthe ... |
null | {
"text": "CORREL ATION TABLE \nCouncil Directive 90/385/EEC Council Directive 93/42/EEC This Regulation \nArticle 1(1) Article 1(1) Article 1(1) \nArticle 1(2) Article 1(2) Article 2 \nArticle 1(3) Article 1(3) first subparagraph Article 1(9) first subparagraph \n— Article 1(3) second subparagraph Article 1(9) secon... |
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