News Medtech Regulations Newsletter

Industry Perspective on the Implementation Status of the MDR/IVDR

Posted on 04.07.2019

With less than one year to go prior to the 26 May 2020 Medical Device Regulation (MDR) Date of Application, the European medical device industry remains deeply concerned that the welcomed new regulatory system will not be ready on time. The very same is true for the In Vitro Diagnostic Medical Device Regulation (IVDR), although implemented in May 2022.

We must not put patients at risk, nor negatively impact healthcare systems and European Member States therefore need to move faster in order to get the new system(s) ready on time.

As part of its “MDR one year to go” advocacy campaign MedTech Europe developed a slide deck calling for an accelerated implementation of the MDR, European wide solutions, and describing 7 concrete and fundamental areas that need addressing with urgency. These include:

1. Speeding up the designation of Notified Bodies
2. Making the (re-)certification procedure work for all products
3. Publishing clear, timely and high-quality guidance in the most urgent areas
4. Deploying the Eudamed database with appropriate specifications and timelines
5. Ensuring timely publication of needed common specifications
6. Ensuring timely harmonization of standards in the highest-priority areas, and
7. Rapidly establishing the new EU reference laboratories and expert panels