Article 10a MDR and IVDR: Decision guide flowchart

With effect from 10 January 2025, Regulation (EU) 2024/1860 amending the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR), introduces a duty of information for medical device manufacturers in the event of a supply interruption or discontinuation. To comply with this obligation, companies must establish structured processes within their operations.

To support medical technology companies in meeting these new regulatory requirements, MedTech Europe in collaboration with AESGP and COCIR, has developed this decision guide flowchart as a visual guide to help stakeholders understand, interpret, and apply Article 10a MDR/IVDR in practice. This resource is based on the official text of MDR/IVDR Article 10a and the European Commission Q&A document published in December 2024, developed in collaboration with stakeholders.

Important note: this flowchart is not legally binding and does not constitute legal or regulatory advice. In case of discrepancies, the official text of MDR/IVDR Article 10a and the European Commission’s Q&A document take precedence. The Associations assume no legal responsibility for its use, and companies are strongly advised to seek their own legal or regulatory guidance before making any decisions based on this document. The Associations reserve the right to update or amend this resource at any time to ensure the information remains current.

For further information, please visit the European Commission’s official resources.

Additional support from BVMed

The German Bundesverband Medizintechnologie (BVMed) provides additional guidance to MedTech companies on implementing the new notification obligation via a legal opinion offering insights into practical implementation prepared by CMS Hasche Sigle. This report is available for download in English language. The MedTech Europe Decision-Making Flowchart and the BVMed Legal Opinion complement each other.