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UE – MDCG 2025-6 : Interplay between the Medical Devices Regulation (MDR) & In vitro Diagnostic Medical Devices Regulation (IVDR) and the Artificial Intelligence Act (AIA) – june 2025

7 Jul 2025 | MDCG

Theme Artificial intelligence Target Audience Manufacturers, notified bodies, competent authorities Products concerned MD and IVD integrating artificial intelligence systems (AIS) In June 2025, the MDCG published a guide concerning the interconnection between the MD...

UE – MDCG 2025-5 Questions & Answers regarding performance studies of in vitro diagnostic medical devices under regulation (EU) 2017/746 – june 2025

7 Jul 2025 | MDCG

Theme Performance studies Target Audience Sponsors of performance studies, manufacturers Products concerned IVD The MDCG published a question and answers document in June 2025 regarding performance studies of in vitro diagnostic (IVD) medical devices conducted under...

UE – MDCG 2025-4 : Guidance on the safe making available of medical device software (MDSW) apps on online platforms – june 2025

7 Jul 2025 | All the News, MDCG

Theme Making available medical device software applications on the market Target Audience Suppliers of medical device software application platforms Products concerned MD and IVD software applications In June 2025, the MDCG published a guide describing the roles and...

UE – MDCG 2025-3 – EMDN Version History – jan 2025

3 Feb 2025 | MDCG

Theme EMDN Target Audience Manufacturer, competent authorities, notified bodies Products concerned MD, IVD In January 2025, the MDCG published an excel table showing the revision history of all EMDN codes added, deleted or modified in 2024. ...

UE – MDCG 2025-2 – Summary of EMDN 2024 Submissions and outcome of annual revision – jan 2025

3 Feb 2025 | MDCG

Theme EMDN Target Audience Manufacturer, competent authorities, notified bodies Products concerned MD, IVD In January 2025, the MDCG published a document presenting the results of the analysis of submissions made during the annual procedure for revising the European...

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UE – MDCG 2025-6 : Interplay between the Medical Devices Regulation (MDR) & In vitro Diagnostic Medical Devices Regulation (IVDR) and the Artificial Intelligence Act (AIA) – june 2025

UE – MDCG 2025-5 Questions & Answers regarding performance studies of in vitro diagnostic medical devices under regulation (EU) 2017/746 – june 2025

UE – MDCG 2025-4 : Guidance on the safe making available of medical device software (MDSW) apps on online platforms – june 2025

UE – MDCG 2025-3 – EMDN Version History – jan 2025

UE – MDCG 2025-2 – Summary of EMDN 2024 Submissions and outcome of annual revision – jan 2025

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UE – MDCG 2025-6 : Interplay between the Medical Devices Regulation (MDR) & In vitro Diagnostic Medical Devices Regulation (IVDR) and the Artificial Intelligence Act (AIA) – june 2025

UE – MDCG 2025-5 Questions & Answers regarding performance studies of in vitro diagnostic medical devices under regulation (EU) 2017/746 – june 2025

UE – MDCG 2025-4 : Guidance on the safe making available of medical device software (MDSW) apps on online platforms – june 2025

UE – MDCG 2025-3 – EMDN Version History – jan 2025

UE – MDCG 2025-2 – Summary of EMDN 2024 Submissions and outcome of annual revision – jan 2025

Search in the Website

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