Implementing The EU MDR Amendment: “Messy” And “A Lot To Figure Out On The Hoof”
The EU Medical Device Regulation amending regulation is not some kind of “bail-out or blanket extension” for manufacturers, medtech expert lawyer Erik Vollebregt warns. But it offers valuable opportunities to already-prepared manufacturers.
You may also be interested in...
The EU Regulation on HTA will see some medtech manufacturers offered scientific advice on planned clinical investigations. According to BSI’s global head of clinical compliance, MDR/IVDR notified bodies can offer valuable expertise and must not be left out of these discussions.
The deadlines for legacy products under the Medical Device Regulation have changed. Here are the essentials that all medtech players need to understand in how the MDR has now been amended.
The EU Council has adopted proposed changes to the EU Medical Device Regulation that will see transition deadlines extended for legacy devices. This completed final legislative step means that the amendments are set to enter force in around a week’s time, on 15 March.