Medical Device Coordination Group (MDCG) updates – Jan to Mar 2024

DateGuidance NoAbout the guidance
12 Mar 2024MDCG 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 70(1) of the MDR, to the Member State(s) in which the clinical investigation is to be conducted, the application shall be accompanied by the documentation referred to in Chapter II of Annex XV of the MDR.

Section 3 of Chapter II of Annex XV of the MDR describes the legally required content of the Clinical Investigation Plan (CIP). Further the sections 2.7 in chapter I, 3.12 chapter II as well as 4 and 6 in chapter III of Annex XV indicate that clinical investigations should be conducted in accordance with good clinical practice.

This guidance document is not legally binding. It has been developed following contribution from national competent authorities, industry and relevant stakeholders and it should therefore be recognised as best practice. It has been written to support sponsors developing their CIP by describing in greater detail what type of information is expected in the respective CIP sections, to pre-empt questions from the competent authorities during the assessment of the clinical investigation application. Moreover, a CIP with the appropriate content will be instrumental in the conduct of the clinical investigation.
6 Feb 2024MDCG 2024-2 Procedures for the updates of the European Medical Device Nomenclature (EMDN)

The EMDN, as established by Article 26 of Regulation (EU) 2017/745 – Medical Device Regulation (MDR) and Article 23 of Regulation (EU) 2017/746 – In Vitro Diagnostic medical devices Regulation (IVDR), will be annually reviewed and updated based on the practical use of the EMDN and feedback from its users. This document lays out the procedures for the annual revision as well as the procedure for ad-hoc requests requiring an expedited review.
6 Feb 2024MDCG 2024-1Guidance on the vigilance system for CE-marked devices
Device Specific Vigilance Guidance (DSVG) Template

The aim of this Device Specific Vigilance Guidance (DSVG) is to harmonise vigilance reporting and provide guidance for manufacturers of Specific Devices.

It provides further clarification for vigilance reporting of Specific Devices to the relevant Competent Authority and should be read in conjunction with the requirements of Regulation (EU) 2017/745 on medical devices (MDR) [1] and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) [2]. This DSVG does not replace or extend any of those requirements.

This document outlines the way to report incidents and serious incidents, defined in Article 2(64) and (65) MDR and in Article 2(67) and (68) IVDR, in accordance with Articles 87 and 88 MDR and Articles 82 and 83 IVDR, which occurred with Specific Devices, to the relevant Competent Authority.