medicines-medical devices-regulatory affairs
Date Guidance No About the Guidance 8 Oct 2024 MDCG 2024-11 Guidance on qualification of in vitro diagnostic medical devices (October 2024) The purpose of this guidance document is to clarify what products fall in scope of Regulation 2017/746 on…
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…
The Medical Device Coordination Group (MDCG) has published a Q & A on the Medical Devices Regulation (EU) 2017/745/ (MDR) regarding clinical investigation. The document MDCG 2021-6 is entitled ‘Regulation (EU) 2017/745 – Questions & Answers regarding clinical investigation’. Who…