About the MDR/IVDR Transition Subgroup

The key objectives of the Transition Subgroup are to:

  • identify areas with the potential for inconsistent application;
  • troubleshoot issues and provide recommendations or clarity, in the form of a ‘questions and answers’ document, on interpretation;
  • where appropriate, seek legal input to underpin proposals;
  • where appropriate, recommend the development of procedures to ensure authorities implement in a consistent manner.


The MDR/IVDR Transition Subgroup has developed some FAQs to provide clarity.

Members of the Transition Subgroup

Members states represented on the subgroup include:


  • Germany (DE)


  • Sweden (SE)
  • Spain (ES)
  • Portugal (PT)
  • United Kingdom (UK)
  • Netherlands (NL)
  • Ireland (IE)
  • Denmark (DK)
  • France (FR)
  • Italy (IT)
  • Belgium (BE)
  • Croatia (HR)
  • Greece (EL)
  • Switzerland (CH)