Medical Device Regulation

Category: compliance Industry: healthcare Author: Year:

The new MDR

A commentary by Miriam Schuh

It’s been official since 5 May 2017: the new European Medical Device Regulation (MDR) has been announced together with the Regulation on In Vitro Diagnostic Devices (IVD) in the Official Journal of the European Community (OJEC). We reported on this in an earlier news item.

Miriam Schuh was interviewed on the new MDR by DeviceMed. She said: “Time will tell whether or not the powers that be have succeeded in formulating the MDR in such a way that it corresponds to the original recitals.” She then went on to explain what challenges the MDR holds for companies and how effective MDR compliance can be put in place.

You can read the article on the home page of DeviceMed. We will be holding a business brunch on this subject on 23 June 2017 in Düsseldorf.

[May 16th, 2017]