| Date | Guidance No | About the guidance |
|---|---|---|
| Sept 2026 | MDCG 2020-16 rev.5 | Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 (September 2026) The changes are as follows: Rule 7 : Clarification of the rationale and revision of examples |
| July 2026 | MDCG 2026-5 | MDCG Position Paper: UDI assignment between manufacturers and distributors This MDCG Position Paper aims at explaining the point to clarify the situation and avoid confusion, misunderstandings or potential misuse arising from differing interpretations between manufacturers and distributors, as well as the EU UDI issuing entities. This should ensure clarity, transparency and consistency across EU Member States in their enforcement of the provisions of the EU Medical Device Regulations on UDI and the operation of Eudamed. |
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medicines-medical devices-regulatory affairs