Official Publication Of EU's MDR Delay Regulation Imminent As Another Hurdle Jumped
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.
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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.
Where are the biggest challenges for notified bodies and manufacturers now there is some experience with the MDR, and can the sector manage the new regulatory requirements successfully?
The European Commission has finally published detailed guidance on the EU IVDR’s classification rules. The IVDR’s completely new classification regime means guidance is urgently needed.