Medi­cal Device Regulation

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.