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European Commission: new update of the manual on borderline products and classification of MDs and IVDDs

2025-10-01

[2025-09-12] In September 2025, the European Commission's Borderline and Classification Working Group published a further update of the reference document on borderline products and classification…contenu réservé à nos abonnés Premium

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European Commission: survey of NBs on the availability of MDs and IVDDs (July 2025 update)

2025-09-30

[2025-07-25] (Open Access) The European Commission continues to publish the results of its survey of Notified Bodies (NBs) with regard to the availability of medical devices (MDs) and in vitro diagnostic medical devices (IVDDs), on the European Union (EU) market. This is the 14th update. Survey background The survey was

Team-NB: update on best practices for submitting technical documentation in accordance with IVDR

2025-10-01

[2025-09-03] Team-NB (the European association of notified bodies for medical devices) published, on September 3, 2025, a new version of its guide on good practice…contenu réservé à nos abonnés Premium

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Team-NB: “1st EU Regulations Discussion Day”.

2025-09-29

[2025-09-19] (Open access) Team-NB (The European Association of Medical devices Notified Bodies) announces its 1st EU Regulations Discussion Day 2025. This event is aimed at small and medium-sized enterprises (SMEs), members of notified bodies and organizations. It aims to encourage exchanges between stakeholders on the future European regulatory framework for

CORE-MD: recommendations for clinical investigations of high-risk medical devices

2025-10-01

[2025-09-16] On September 16, 2025, the CORE-MD (Coordinating Research and Evidence for Medical devices) consortium published an article in The Lancet Regional Health - Europe…contenu réservé à nos abonnés Premium

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Swissmedic: new information on swissdamed

2025-10-01

[2025-08-15] Swissmedic, the Swiss Agency for Therapeutic Products, updated its "swissdamed" page on August 15, 2025. Swissdamed is the database for the registration of economic…contenu réservé à nos abonnés Premium

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Regulatory and Standards Flash

European Commission: new update of the manual on borderline products and classification of MDs and IVDDs

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European Commission: survey of NBs on the availability of MDs and IVDDs (July 2025 update)

Team-NB: update on best practices for submitting technical documentation in accordance with IVDR

Contenu réservé à nos abonnés Premium. S’abonner

Team-NB: “1st EU Regulations Discussion Day”.

CORE-MD: recommendations for clinical investigations of high-risk medical devices

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Swissmedic: new information on swissdamed

Contenu réservé à nos abonnés Premium. S’abonner

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ARTICLES RECENTS

Proposed simplification of MDR and IVDR

The Flash by DMEXPERTS No.139 – Premium Edition

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DMEXPERTS Flash Editorial N°139

CORE-MD: recommendations for clinical investigations of high-risk medical devices

European Commission: new update of the manual on borderline products and classification of MDs and IVDDs

Flash réglementaire et normatif