medicines-medical devices-regulatory affairs
Date Guidance No About the guidance 17 Apr 2024 MDCG 2024-5 Guidance on content of the Investigator’s Brochure (IB) for clinical investigations of medical devices – April 2024 When a sponsor of a clinical investigation shall submit an application according…
Date Guidance No About the guidance 12 Mar 2024 MDCG 2024-3 Guidance on content of the Clinical Investigation Plan for clinical investigations of medical devices (March 2024) When a sponsor of a clinical investigation submits an application according to article…
Guidance No. About the guidance MDCG 2023-7 Guidance on exemptions from the requirements to perform clinical investigations pursuant to Article 61(4)-(6) MDR – December 2023 This guidance is intended to clarify the exemptions from the requirement to perform clinical investigations…
Date Guidance No About the guidance 30 Jun 2023 Add 1 – MDCG Position Paper on the application of Art.97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of a MDR certificate Addendum…
Date Guidance No About the guidance 14 Feb 2023 MDCG 2023-3 – Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices – February 2023 This document aims to clarify important terms…
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…
Guidance No About the guidance MDCG 2021-22 Rev.1 Clarification on “first certification for that type of device” and corresponding procedures to be followed by notified bodies, in context of the consultation of the expert panel referred to in Article 48(6)…
The Medical Device Coordination Group (MDCG) has published the following updates: Guidance No About the guidance MDCG 2022-11 MDCG Position Paper: Notice to manufacturers to ensure timelycompliance with MDR requirements From 27 May 2024, the MDR will be fully applicable…
The Medical Device Coordination Group (MDCG) has published the following updates: MDCG number Notes MDCG 2021-26 Questions and Answers on repackaging & relabelling activities under Article 16 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746This document presents questions and answers…
The Medical Device Coordination Group (MDCG) has published the following updates: MDCG number Notes MDCG 2021- 23 Guidance for notified bodies, distributors and importers on certification activities in accordance with Article 16(4) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746…