Christophe Saillet, Author at DMEXPERTS - Veille, formation et conseil pour les dispositifs médicaux- Réseau de consultants

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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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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MHRA: standard model for PMSR

2025-10-01

[2025-09-05] On September 5, 2025, the UK Medicines and Healthcare products Regulatory Agency (MHRA) published a standard template for the post-market surveillance report (PMSR) for…contenu réservé à nos abonnés Premium

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Health Canada: Guidance for determining medical device application type

2025-09-18

[2025-08-29] On August 29, 2025, Health Canada published new guidance for licence or authorization applications for groups of medical devices. This new 32-page guide is…contenu réservé à nos abonnés Premium

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Christophe Saillet

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

Contenu réservé à nos abonnés Premium. S’abonner

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

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

Contenu réservé à nos abonnés Premium. S’abonner

MHRA: standard model for PMSR

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Health Canada: Guidance for determining medical device application type

Contenu réservé à nos abonnés Premium. S’abonner

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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

Malaysia becomes an affiliate member of MDSAP

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