THE EU MEDICAL DEVICE REGULATION 2017 /745 : A new opportunity to be ready in time (1/6)

As a Language Service Provider, specialized in translation for the Pharmaceutical industry, we have been approached by many of our clients regarding the New European Medical Devices Regulation (EU MDR 2017/745) that should have become mandatory in all EU member states by May 26, 2020. Due to the Covid-19 crisis, the deadline was postponed to May 2021.

This MDR that was initially published in 2017 is actually an update of the former Medical Device Directive (MDD) but it brings a substantial change compared to its predecessor by mainly promoting a life-cycle approach to safety, enhancing transparency as well as providing adequate access to information.

Another important aspect is that not only all CE-marked products will need to be re-certified under the new MDR in order to retain the CE mark and stay on the market, but a whole new range of devices has been added to the list of devices falling under the new regulation.

Although transitional periods are planned, it is highly recommended to get ready sooner than later as all professionals will get busier as May 26 draws closer. And despite the fact some deadlines may still change, manufacturers are advised to address the Technical Documentation topic without delay as it may turn out to be the most time-consuming part. Baguette Translations has acquired the knowledge and the resources necessary to accompany you during and after the ‘big’ shift.