Information on the Upcoming Medical Devices Regulations

You will find hereafter information on the upcoming Medical Devices Regulation, in particular its implementation by policy-makers as well as parties affected by the law.

As you are already aware, after a political agreement was reached between the Council, the EU Parliament and Commission for both Medical Devices Regulation (MDR) and in vitro diagnostics Regulation (IVDR) proposals in June, the consolidated legal texts were translated in the 24 EU languages during summer, and are now being checked for legal conformity. In this context, in particular the provisions concerning the transitional periods, e.g. validity of certificates issued prior to the entry into force of the new Regulation, are reviewed. Formal adoption is expected by Q2 of 2017, and full application by 2020 for the MDR, and by 2022 for the IVDR.

Introducing major changes, the Medical Devices text will have significant impacts on all parties involved in manufacturing, distributing, assessing medical devices and regulating their entry onto the market. The new Regulation also provides for more than 50 implementing and delegated acts, i.e. acts adopted by the European Commission to ensure uniform conditions and to supplement or amend certain “non-essential elements” of the Regulation. The Commission is currently listing those implementing/delegated acts which need to be adopted before the new Regulation will be adopted, taking into consideration the following criteria:

  1. structural implementing acts, without which the text cannot apply;
  2. acts critical for uniform implementation;
  3. acts that will become needed, later on, for uniform implementation;
  4. acts that can be triggered, on an ad hocbasis, if need be.

It is deemed that the acts that are structural to and critical for implementation (10-30 acts) revolve around the chapters on

  • Notified Bodies
  • Clinical evaluation and clinical investigations
  • Post-market surveillance and vigilance
  • Classification and
  • Conformity assessment.

In parallel, the newly-introduced Common Specifications also need to be developed, while some issues will have to be addressed through soft law (e.g. Guidance) in order for manufacturers to comply with the MDR.

You can monitor progress made on the MDR through the Better Regulation Portal, which can be accessed here and this portal enables feedback on draft acts.

 

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Published on 5. December 2016 in News EU