Notified bodies are crucial to the medtech regulatory system. But for them to live up to their full potential and exercise delegated state authority in accordance with principles of good administration there needs to be greater regulation of the market for their services and additional controls on these entities.
Why Notified Bodies Are Now The Focus Of Centralized Oversight Efforts
Proposals for substantial changes to oversight of medtech notified bodies are likely to be part of the European Commission’s targeted evaluation of the MDR and IVDR, EU medtech lawyer, Erik Vollebregt, tells Medtech Insight.
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