medicines-medical devices-regulatory affairs
Date Guidance No About the guidance 10 Jul 2025 MDCG 2025-7 Position Paper: Timelines of implementation of ‘Master UDI-DI’ to contact lenses and spectacle frames, spectacle lenses and ready-to-wear reading spectacles This MDCG Position Paper aims at clarifying the timelines…
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…
The Medical Device Coordination Group (MDCG) has published the following updates: Guidance No About the guidance MDCG 2022-2 Guidance on general principles of clinical evidence for In Vitro Diagnosticmedical devices (IVDs) This document outlines the general principles of clinical evidence…
The Medical Device Coordination Group (MDCG) has published the following updates: MDCG number About the guidance MDCG 2021-28 Substantial modification of clinical investigation under Medical Device RegulationIn the absence of the European database on medical devices (EUDAMED), a series of…
The Medical Device Coordination Group (MDCG) has published the following updates: MDCG Number Notes MDCG 2021-20 Instructions for generating CIV-ID for MDR Clinical Investigations The purpose of generating a CIV-ID is to create a European tracking number which can be…