This flowchart, co-signed by AESGP, COCIR and MedTech Europe, 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.

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