medicaldeviceslegal

Medical devices legal and regulatory blog

  • About Erik Vollebregt

Category: Notified Body

Happy IVDR day!

Finally remote initial audits, or not (yet)?

New MDCG guidance on temporary extraordinary measures related to medical device Notified Body audits during COVID-19 quarantine orders and travel restrictions

The MDR and the Covid-19 recommendation – a possible template for fixing the MDR and IVDR bottleneck

Welcome to 2020 – year of the proof of the MDR pudding

A not so happy MDR and IVDR Christmas Carol

Bottleneck of bottlenecks for notified body capacity

Don’t give me Brexit problems, give me Brexit scenarios

First notified body EU MDR designated!

MDR and IVDR in 2019: up or out, sink or swim

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