Update – MDCG 2020-16 rev.4 – Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 (March 2025)
This guidance, relating to the application of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) addresses the classification of in vitro diagnostic medical devices (IVDs) and provides clarifications on the classification rules as set out under Annex VIII. This classification guidance also applies to diagnostic or information society services performed on EU patients or devices put in to service through distance sales.
Read the news announcement published by Directorate-General for Health and Food Safety on 18 March 2025.
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lsgilbert (23 avril 2025). Update – MDCG 2020-16 rev.4 – Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 (March 2025). ELSIBI. Consulté le 12 janvier 2026 à l’adresse https://doi.org/10.58079/13skz





