Can EU Regulations Be Changed To Allow For More Time? MedTech Europe Says 'Yes'
Huge numbers of products risk failing to comply the new EU regulations in time. Are efforts to extend deadlines legally and practically possible and will they be supported? MedTech Europe's Oliver Bisazza talks with Medtech Insight.
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Medtech stakeholders were reminded recently at the UK's largest regulatory forum that even those willing to make the best of Brexit are still working in the dark. The lack of useful government outreach is frustrating most efforts to secure business continuity. And that is without factoring in the huge regulatory changes that the EU's twin medical device regulations – the MDR and IVDR – will bring.
The EU medtech sector, seeing itself heading for a crisis, is hoping the authorities will imminently extend deadlines for the Medical Device and IVD Regulations. What more do we know after last week's crucial Medical Device Coordination Group meeting?
There's been progress toward designating notified bodies against the EU's medtech regulations, but the developments need to be scrutinized so that the sector preserves a sense of reality about capacity issues, MedTech Europe's Oliver Bisazza says.