COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices THE COUNCIL OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Economic Community, and in particular Article 100a thereof, Having regard to the proposal from the Commission (1), In cooperation with the European Parliament (2),

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 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and …

The Medical Device Directive — Council Directive 93/42/EEC of 14 June 1993 concerning medical devices —is intended to harmonise the laws relating to medical devices within the European Union.

Medical devices are products or equipment intended for a medical purpose. In the European Union (EU) they must undergo a conformity assessment to demonstrate they meet legal requirements to ensure they are safe and perform as intended.

Oct 11, 2007 · European databank 1. Regulatory data in accordance with this Directive shall be stored in a European database accessible to the competent authorities to enable them to carry out their tasks relating to this Directive on a well-informed basis. …

2017年5月5日，欧盟官方期刊（Official Journal of the European Union）正式发布了欧盟医疗器械法规（REGULATION (EU) 2017/745，简称“MDR”）。 MDR将取代Directives 90/385/EEC （有源植入类医疗器械指令）and 93/42/EEC（医疗器械指令）。 依据MDR Article 123的要求，MDR于2017年5月26日正式生效，并与2020年5月26日期正式取代 MDD （93/42/EEC）和 AIMDD （90/385/EEC）。 MDR实施之后，在三年过渡期内仍然可以按照MDD和AIMDD申请 CE证书 …

With effect from 26 May 2021, Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices replaced Council Directive 90/385/EEC on active …

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 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

The European Commission has adopted several implementing measures based on the medical devices directives. These measures concern, among other things, medical devices manufactured using tissues of animal origin, the classification of certain medical devices, and common technical specifications for in vitro diagnostic devices (IVDs), listed in ...

2017年5月5日，欧盟官方期刊（Official Journal of the European Union）正式发布了欧盟医疗器械法规（REGULATION (EU) 2017/745，简称“MDR”）。 MDR将取代Directives 90/385/EEC （有源植入类医疗器械指令）and 93/42/EEC（医疗器械指令）。 依据MDR Article 123的要求，MDR于2017年5月26日正式生效，并与2020年5月26日期正式取代 MDD （93/42/EEC）和 AIMDD （90/385/EEC）。 MDR实施之后，在三年过渡期内仍然可以按照MDD和AIMDD申请 CE证书 …