The European Commission has announced today that it is working on a proposal to postpone the application date of the Medical Devices Regulation 2017/745 (“MDR”) for one year. This proposal is to relieve the pressure on national authorities, notified bodies, manufacturers and other actors so they can focus on responding to the COVID-19 outbreak. According to the Commission spokesman, the goal is:
“to submit this proposal early April and we call on Parliament and on Council to adopt it quickly, as the deadline for entry into force is at the end of May.”
This will be welcome news to all manufacturers of medical devices intended for the EU market, as well as other economic operators in the supply chain. The postponement of the implementation date will allow companies to deploy resources to address the current pandemic and will give them extra time to become MDR-compliant.
InsideEULifeSciences will continue to monitor developments and publish updates as they come in.