Agreement has finally been reached over the new European Union Medical Device Regulation (MDR) and is expected to come into effect in June 2017. MDR was approved by the European Parliament on April 5, 2017 and was published in the Official Journal of the European Union on 5th May 2017. This new Regulation, whose full name is 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, will consolidate two existing legal provisions and replace both the current Medical Device Directive (93/42/EEC) and the Active Implantable Medical Device Directive (90/385/EEC).
The new Medical Device Regulation is complex and the changes it embodies are significant. Our white paper serves as a first step for medical device manufacturers in the EU Market to better understand the immediate MDR implications by:
- Analyzing the most influential changes and highlighting their implications for regulated medical device companies
- Providing practical steps that medical device manufacturers should take as soon as possible to prepare for this substantial change in the European regulatory environment