Title stringclasses 1
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value | Chapters dict | Annexes dict |
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REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 andRegulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC | (1) Council Directive 90/385/EEC (3) and Council Directive 93/42/EEC (4) constitute the Union regulator y framew ork
for medical devices, other than in vitro diagnostic medical devices. However , a fundamental revision of those
Directives is needed to establish a robust, transparent, predictable and sustainable regu... | {
"articles": {
"Article 1": {
"heading": "Subject matter and scope",
"text": "1.This Regulation lays down rules concerning the placing on the market, making available on the market or putting into service of medical devices for human use and accessories for such devices in the Union. This Regulation ... | {
"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... |
"REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical d(...TRUNCATED) | "(1) Council Directive 90/385/EEC (3) and Council Directive 93/42/EEC (4) constitute the Union regu(...TRUNCATED) | {"articles":{"Article 1":null,"Article 10":{"heading":"General obligations of manufacturers","text":(...TRUNCATED) | {"text":"TECHNIC AL DOCUMENT ATION \nThe technical documentation and, if applicable, the summar y th(...TRUNCATED) |
"REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical d(...TRUNCATED) | "(1) Council Directive 90/385/EEC (3) and Council Directive 93/42/EEC (4) constitute the Union regu(...TRUNCATED) | {"articles":{"Article 1":null,"Article 10":null,"Article 100":null,"Article 101":null,"Article 102":(...TRUNCATED) | {"text":"TEC HNIC AL DOCUMENT ATION ON POST -MARKET SUR VEILL ANCE \nThe technical documentation on (...TRUNCATED) |
"REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical d(...TRUNCATED) | "(1) Council Directive 90/385/EEC (3) and Council Directive 93/42/EEC (4) constitute the Union regu(...TRUNCATED) | {"articles":{"Article 1":null,"Article 10":null,"Article 100":null,"Article 101":null,"Article 102":(...TRUNCATED) | {"text":"out in Sections 14 and 15 conf orm to the type descr ibed in the EU type-examination certif(...TRUNCATED) |
"REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical d(...TRUNCATED) | "(1) Council Directive 90/385/EEC (3) and Council Directive 93/42/EEC (4) constitute the Union regu(...TRUNCATED) | {"articles":{"Article 1":null,"Article 10":null,"Article 100":null,"Article 101":null,"Article 102":(...TRUNCATED) | {"text":"CE MARKING OF CONFORMIT Y \n1. The CE marking shall consist of the initials ‘CE’ takin(...TRUNCATED) |
"REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical d(...TRUNCATED) | "(1) Council Directive 90/385/EEC (3) and Council Directive 93/42/EEC (4) constitute the Union regu(...TRUNCATED) | {"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) |
"REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical d(...TRUNCATED) | "(1) Council Directive 90/385/EEC (3) and Council Directive 93/42/EEC (4) constitute the Union regu(...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) |
"REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical d(...TRUNCATED) | "(1) Council Directive 90/385/EEC (3) and Council Directive 93/42/EEC (4) constitute the Union regu(...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) |
"REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical d(...TRUNCATED) | "(1) Council Directive 90/385/EEC (3) and Council Directive 93/42/EEC (4) constitute the Union regu(...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) |
"REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical d(...TRUNCATED) | "(1) Council Directive 90/385/EEC (3) and Council Directive 93/42/EEC (4) constitute the Union regu(...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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