Article | November 16, 2022

EU Annex 11: How To Stay Compliant

By Taylor Davidson, Florence Healthcare


EU Annex 11 lays out the European Union’s regulations for using computerized systems during clinical trials. Any sponsor or site who wants their new medical treatment approved in the EU must follow Annex 11. 

In this post, we’ll answer the questions: 

  • What is Annex 11?
  • Does Annex 11 apply to clinical trials? 
  • Does Annex 11 apply to medical devices? 
  • What is the difference between 21 CFR Part 11 and Annex 11? 
  • How can you stay compliant with Annex 11? 

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