2025-10-01 - DMEXPERTS - Veille, formation et conseil pour les dispositifs médicaux- Réseau de consultants

MDCG: proposed template and Q&A for the trend report

2025-10-01

[2025-09-18] On September 18, 2025, the Post-Marketing Surveillance and Vigilance working group of the MDCG (Medical Device Coordination Group) posted a number of working documents…contenu réservé à nos abonnés Premium

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Master UDI-DI regulations for spectacle frames, spectacle lenses and ready-to-wear spectacles published!

2025-10-01

[2025-09-23] (Open access) Delegated Regulation (EU) 2025/1920 on the unique identification of optical medical devices (spectacle frames, spectacle lenses and ready-to-wear reading spectacles) was published in the Official Journal of the European Union on September 23, 2025. It follows the public consultation we reported on earlier this year. We invite

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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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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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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October 1, 2025

MDCG: proposed template and Q&A for the trend report

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Master UDI-DI regulations for spectacle frames, spectacle lenses and ready-to-wear spectacles published!

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

Contenu réservé à nos abonnés Premium. S’abonner

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

Contenu réservé à nos abonnés Premium. S’abonner

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

The Flash by DMEXPERTS No.139 – Premium Edition

End-of-year offers: 20% off on our online MDR training and offer on our watch service

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

Malaysia becomes an affiliate member of MDSAP

Flash réglementaire et normatif