Starting from 10 January 2025, Regulation (EU) 2024/1860 introduces new requirements under the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR), mandating that medical device manufacturers provide information in cases of supply disruptions or product discontinuation. To comply, companies must implement structured internal processes to manage these obligations effectively.
To assist medical technology companies in navigating these new regulatory requirements, MedTech Europe, in collaboration with AESGP and COCIR, has developed a decision-making flowchart. This visual guide helps stakeholders interpret and apply Article 10a MDR/IVDR, offering practical insights based on the official MDR/IVDR text and the European Commission’s Q&A document published in December 2024, which was developed with input from industry stakeholders.
Key Considerations
- This flowchart is a non-binding tool and does not constitute legal or regulatory advice.
- In case of discrepancies, the official text of Article 10a MDR/IVDR and the European Commission’s Q&A document take precedence.
- MedTech Europe, AESGP, and COCIR assume no legal responsibility for its use. Companies should seek independent legal or regulatory guidance before making decisions based on this document.
- The flowchart may be updated periodically to ensure its relevance and accuracy.
- For official information, visit the European Commission’s resources.
Additional Support from BVMed
The German Bundesverband Medizintechnologie (BVMed) offers further guidance on implementing the new notification obligations. A legal opinion prepared by CMS Hasche Sigle provides insights into practical application and is available for download in English.
The MedTech Europe Decision-Making Flowchart and the BVMed Legal Opinion serve as complementary resources, supporting companies in ensuring compliance with the new regulatory framework.
The decision making flowchart can be accessed using the following link
