BSI: Medical devices whitepapers

The proposed EU regulations for medical and in vitro diagnostic devices: An overview of the likely outcomes and consequences for the market

Written by expert authors, Gert Bos, Head of Regulatory and Clinical Affairs at BSI and Erik Vollebregt, Partner at Axon Lawyers.
The proposals for the new medical devices (MDR) and IVD regulations (IVDR) will provide a new regulatory framework for medical devices in the EU for the coming decades. Although crucial elements of the regulations are still subject to political debate, one thing is clear – the regulations will cause important changes for you. Use this whitepaper to find out how to prepare for these changes.


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Forthcoming whitepapers within the medical devices series will cover subject areas as follows:

  • Generating clinical evaluation reports: A guide to effectively analysing medical device safety and performance
  • The digital patient
  • What medical device manufactures need to know about FDA’s Unique Device Identification Final Rule
  • Post-market surveillance
  • Usability engineering