EU Medical Device Regulation 2017

In Generalby Alena EckertLeave a Comment

By 25 May 2017 the new EU Medical Device Directive 2017/745/EU (MDR) enters into force and replaces the existing Council Directives 93/42/EEC (MDD) and 90/385/EEC (AIMD). The new regulations will apply after a transitional period of three years on 26 May 2020.

EU Medical Device Regulation

Compared to the repealing directive the MDR has a 100 more articles. So manufacturers are confronted with additional obstacles by bringing their medical devices to the market. The general rules of MEDDEV Guideline (Chapter VI and Annex XIV) are integral part of the MDR, either ISO 14155 (Chapter VI and Annex XV)

 

 

Leave a Comment