medicines-medical devices-regulatory affairs
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…
Date Guidance No About the guidance 19 Dec 2025 MDCG 2025–10 Guidance on post-market surveillance of medical devices and in vitro diagnostic medical devices (December 2025) Unless otherwise stated, this guidance is applicable to all medical devices (MDs) and in…
Date Guidance No About the guidance 26 Aug 2025 MDCG 2024-14 – rev.1 Guidance on the implementation of the Master UDI-DI solution for contact lenses This document aims to provide guidance in the implementation of Master UDI-DI rules for contact…
Date Guidance No About the guidance 19 Jun 2025 MDCG 2025-6 FAQ on Interplay between the Medical Devices Regulation & In vitro Diagnostic Medical Devices Regulation and the Artificial Intelligence Act (June 2025) This document provides a first set of…
Date Guidance No About the guidance 18 Mar 2025 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…
Date Guidance No About the Guidance 18 Dec 2024 MDCG 2022-3 rev.1 Verification of manufactured class D IVDs by notified bodies All the changes to the document are reported on page 2. This document aims to provide guidance to notified…
Date Guidance No About the Guidance 25 Sep 2024 MDCG 2021-4 rev.1 Application of transitional provisions for certification of class D in vitro diagnostic medical devices under Reg (EU) 2017/746 – September 2024 This essentially a Q&A document.The revisions are…
Guidance No About the guidance MDCG 2022-4 rev.1 Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR with regard to devices covered by certificates according to the MDD or the AIMDD, Revision 1 – December…