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The EU has up-ended its entire medical device oversight system — replacing its three current guidance directives with two massive regulations that bind devicemakers to a variety of new requirements. The new rules:
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- Extend the scope and reclassification of devices
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- Increase premarket scrutiny for high-risk devices
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- Reinforce rules for clinical evidence
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- Tighten post-market surveillance requirements
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- Strengthen supervision of notified bodies by regulatory authorities
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Understanding the New EU Medical Device Regulations directs you through the new MDR and in vitro diagnostic device regulations (IVDR) and explains the new provisions and what they’ll mean for your business. You’ll learn that:
- All notified bodies will need to reapply for certification
- The EU’s medical devices database, Eudamed, will now contain UDI data, single registration numbers for all economic operators, accreditation and designation data for notified bodies, and more
- Devicemakers will have to appoint a specific person to take responsibility for regulatory compliance
- Turn-around time for reporting adverse events will drop from 30 days to only 15 days
- The EU standard EN ISO 13485, recently updated to incorporate changes made in 2016, will have to be revised again
You need to start planning now. The EU transitions to the new medical device requirements by June 2020 and new in vitro diagnostic regulations by June 2024.
Order your copy of Understanding the New EU Medical Device Regulations for an in-depth exploration of the new rules.
Order Your Copy Today
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