Inspiring trust for a more resilient world.

Medical device clinical investigations – What’s new under the MDR?

This paper discusses important new requirements for pre-market and post-market clinical investigations under the European MDR. It also addresses:

  • the importance of defining the regulatory purpose of a study
  • the relationship of a clinical investigation with quality management system (QMS) practices
  • strategies for conducting a successful clinical investigation, including the importance of defining the steps for its planning and conduct

I have read the BSI Privacy Notice and consent to the processing of my personal data