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.

Resources

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

• FAQs – MDR Transitional provisions
• FAQs – IVDR Transitional provisions

Members of the Transition Subgroup

Members states represented on the subgroup include:

Chair

• Germany (DE)

Members

• 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)