This flowchart, co-signed by AESGP, COCIR and MedTech Europe (the Associations), has been
developed to support companies in implementing a structured decision-making process in accordance
with the requirements of Article 10a MDR/IVDR, introduced by Amending Regulation (EU) 2024/1860.
It is based on the text of Article 10a MDR/IVDR itself, as well as the Q&A document which has been
developed by the European Commission in collaboration with stakeholders and was published in
December 2024.
This flowchart is not legally binding and does not constitute legal or regulatory advice. In case of any
discrepancies, the official text of Article 10a and the European Commission’s Q&A document shall take
precedence over this flowchart. The Associations accept no legal responsibility for the use of this
flowchart, and companies should seek their own legal or regulatory advice before making any decisions
based on its content. The Associations reserve the right to change or amend this document at any time
without notice in order to keep the information up to date.