Medical devices

Regulation (EU) 2017/745

 

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

 

Summary list of titles and references of harmonised standards

The summary below consolidates the references of harmonised standards published by the Commission in the Official Journal of the European Union (OJ). It reproduces information already published in the L series of the OJ. It contains all references which, when the summary was generated, still provided a presumption of conformity together with references already withdrawn from the OJ.

The Commission services provide this summary for information purposes only. Although they take every possible precaution to ensure that the summary is updated regularly and is correct, errors may occur and the summary may not be complete at a certain point in time. The summary does not as such generate legal effects.

 

Regulation (EU) 2017/745 on medical devices - Summary list as pdf document

Document date: 05/01/2022 - Created by GROW.H.3 - Publication date: n/a - Last update: 27/01/2022

Download links:欧盟官网下载链接

https://ec.europa.eu/docsroom/documents/48579

 

 

了解更多：MDR认证  医疗器械CE认证