The Medical Devices Regulation – (EC) 2017/745 – was supposed to come into force on 26 May 2020 and should replace the previous medical devices directives, namely Directive 93/42/EEC on medical devices and Directive 90/385/EEC on active implantable medical devices.
In view of the current corona crisis, on April 3, 2020, the Commission adopted a proposal to postpone the application date of the Medical Device Regulation (MDR) for one year. This is intended to give member states, notified bodies, manufacturers and economic actors the opportunity to primarily fight the COVID-19 pandemic.
In addition, the Commission should be able to adopt Union-wide derogations in response to national derogations concerning conformity assessment procedures pursuant to Directives 90/385/EEC or 93/42/EEC for a limited time in order to address potential shortages of vitally important medical devices in an effective manner Union wide.
The current proposal has met with approval from many sides and is an important signal to all medical device companies. In concrete terms, this means that there will be fewer bureaucratic hurdles in the approval of medical devices, especially when this concerns products necessary for the medical care of the population in view of the COVID-19 pandemic. This will also make it easier for companies that have not previously produced medical devices to start producing necessary products.
The Commission therefore calls on the Council of EU Member States and the European Parliament to adopt the proposal rapidly.
For further information see: Proposal for amending Regulation (EC) 2017/745 (COM/2020/144 final)