Filter by
Medical Devices - Sector - Latest updates (143)
RSSOverview of language requirements for manufacturers of medical devices
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)
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
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 2024-1 - Device Specific Vigilance Guidance (DSVG) Template - January 2024
MDCG 2024-2 - Procedures for the updates of the EMDN - February 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
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
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 - December 2023
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
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 2023-6 - 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
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
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
Commission Implementing Regulation (EU) 2023/2713 of 5 December 2023 designating European Union reference laboratories in the field of in vitro diagnostic medical devices
Designation of EU reference laboratories for high-risk 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
Study supporting the monitoring of availability of medical devices on the EU market - Surveys for MD and IVD manufacturers and authorised representatives
Update - Rev 1 - MDCG Position Paper: Notice to manufacturers and notified bodies to ensure timely compliance with MDR and IVDR requirements - November 2023
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
Commission Delegated Regulation (EU) 2023/2197 as regards the assignment of Unique Device Identifiers for contact lenses
Commission Delegated Regulation (EU) 2023/2197 as regards the assignment of Unique Device Identifiers for contact lenses
MDCG 2023-4 - Medical Device Software (MDSW) – Hardware combinations Guidance on MDSW intended to work in combination with hardware or hardware components
MDCG 2023-4 - Medical Device Software (MDSW) – Hardware combinations Guidance on MDSW intended to work in combination with hardware or hardware components
Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices (September 2023)
Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices (September 2023)
Q&A on transitional provisions for products without an intended medical purpose covered by annex XVI of the MDR
Q&A on transitional provisions for products without an intended medical purpose covered by annex XVI of the MDR