medicines-medical devices-regulatory affairs
Date Guidance No About the guidance 10 Jan 2025 MDCG 2024-7 rev.1 MDCG 2024-7 Annex Preliminary assessment review (PAR) form template (MDR) Annex to Application Form & PAR Template MDR (List of documents) 7 Jan 2025 MDCG 2023-3 rev.2 Questions and…
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…
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…