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Medical Devices - Sector - Latest updates (147)
RSSMDCG 2024-5 - Guidance on the Investigator’s Brochure content - April 2024
Update - MDCG 2022-9 rev.1 - Summary of safety and performance template - April 2024
MDCG 2024-4 - Safety reporting in performance studies of in vitro diagnostic medical devices under Regulation (EU) 2017/746 - April 2024
A Study and dashboard on reprocessing and reuse of single-use-devices in the EU
Overview of language requirements for manufacturers of medical devices
MDCG 2024-3 - Guidance on content of the Clinical Investigation Plan for clinical investigations of medical devices (March 2024)
Expression of interest open – Possible second call for EU reference laboratories for high-risk in vitro diagnostic medical devices
MDCG 2024-1 - Device Specific Vigilance Guidance (DSVG) Template - January 2024
MDCG 2024-2 - Procedures for the updates of the EMDN - February 2024
Commission proposes to extend transition periods for certain IVDs, gradual roll-out of Eudamed and an information obligation in case of interruption of supply
Monitoring of availability of medical devices on the EU market
MDCG 2023-7 - Guidance on exemptions from the requirements to perform clinical investigations pursuant to Article 61(4)-(6) MDR and on ‘sufficient levels of access’ to data needed to justify claims of equivalence - December 2023
Update - MDCG 2021-27 - Rev.1 - Questions and Answers on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 - December 2023
MDCG 2023-6 - Guidance on demonstration of equivalence for Annex XVI products - A guide for manufacturers and notified bodies - December 2023
MDCG 2023-5 - Guidance on qualification and classification of Annex XVI products - A guide for manufacturers and notified bodies - December 2023
Update - MDCG 2021-6 - Rev.1 - Regulation (EU) 2017/745 – Questions & Answers regarding clinical investigation - December 2023
Commission Implementing Regulation (EU) 2023/2713 of 5 December 2023 designating European Union reference laboratories in the field of in vitro diagnostic medical devices
On 5 December 2023, the European Commission adopted an implementing act designating 5 EU reference laboratories (EURLs) in the field of in vitro diagnostic medical devices (IVDs).
Study supporting the monitoring of availability of medical devices on the EU market - Surveys for MD and IVD manufacturers and authorised representatives
Update - MDCG 2022-11 - Rev 1 - MDCG Position Paper: Notice to manufacturers and notified bodies to ensure timely compliance with MDR and IVDR requirements - November 2023