MDR Delay: Adoption Now A Formality Following European Parliament Vote
EU industry will be celebrating, albeit in lockdown, as the EU proposal for a one-year delay to the MDR has made it through the European Parliament and is on track to become law within the next month.
You may also be interested in...
With the recent EU decision to postpone the Medical Device Regulation by a year, what factors do medtech manufacturers need to consider when deciding the time to submit applications?
It now looks certain that the EU will succeed in delaying the official start date of the EU’s Medical Devices Regulation by a year, and with it will come new commission powers to allow non-CE marked devices onto the market too.
Eighteen years of free trade threatens to come to a sudden stop, as a result of the stalemate in the market access agreement between Switzerland and the EU. Industry association Swiss Medtech is advising local medtech manufacturers to find notified bodies and authorized representatives based in the EU. However, local company SQS remains confident of its ongoing notified body role.