Medical Device Regulations Update

On March 7, 2017, the Council of the EU voted unanimously to adopt the Medical Device Regulations (MDR) and In Vitro Diagnostics Regulations (IVDR) while the European Parliament will have a formal vote on the regulations on March 20, 2017. Once voted on, both regulations will be published by late April or early May. Accordingly, the MDR will become applicable in three years (2020), while the IVDR will become applicable in five years (2022).

European lawmakers started the process of overhauling the underlying EU legislation in 2012. Finally, after much debate draft versions were released in May of 2016. The drafts included measures to:

  • Tighten regulation of notified bodies;
  • Provide stricter post-market surveillance to monitor faulty products;
  • Increase patient protection during clinical trials, and
  • Increased data requirements for study sponsors.

The final regulations retain much of the same information; however, they have undergone a “legal-linguistic review” to ensure coherency between all official EU languages.

A statement by the Council of the European Union states:

“the new regulations aim at modernizing the existing legislative framework for the marketing of medical devices and to overcome legal gaps, thereby supporting innovation and the competitiveness of the medical device industry. They should further strengthen patient safety, notably through the introduction of more stringent procedures for conformity assessment and for post market surveillance and through requirements on manufacturers to generate clinical data providing evidence on safety, performance and any undesirable side-effects. They should also allow rapid and cost-efficient market access for innovative medical devices.”

The three-year interim period will allow medical device and IVD manufacturers time to adjust and prepare for the stricter regulations.

 

Check our earlier articles on MDR and IVDR for more information:

European Union’s New Medical Device Regulation

Recent European Developments

To read the final versions in their entirety:

Europe In Vitro Diagnostic Regulation

Europe Medical Device Regulation (MDR)