2025-09-27 - DMEXPERTS - Veille, formation et conseil pour les dispositifs médicaux- Réseau de consultants

End-of-year offers – PREMIUM subscribers: 20% off on MDR online training and exclusive offers on our watch services *.

2025-09-27

[2025-10-02] (Open access) To round off 2025 on a high note, take advantage of our exclusive promotions to train and anticipate your regulatory and standards watch needs. MDR online training (EU) 2017/745 Would you like to learn about the European Medical Device Regulation (EU) 2017/745, known as “MDR”? Take advantage

European Commission: call for evidence on MDR and IVDR

2025-09-27

[2025-09-08] (Open access) The European Commission launched a call for evidence on September 8, 2025, to prepare a targeted revision of European regulations on medical devices (MD) and in vitro diagnostic medical devices (IVDD). The call for evidence is available in all European Union (EU) languages. You will need to

IMDRF: new report on document implementation

2025-09-27

[2025-09-01] On September 1st, 2025, the IMDRF (International Medical Device Regulators Forum) published its annual report summarizing the degree of document implementation by the various…contenu réservé à nos abonnés Premium

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HAS: evaluation principles for Digital Medical Devices (DMD)

2025-09-27

[2025-09-10] On September 10, 2025, France's HAS (Haute Autorité de Santé) published a press release setting out the principles for evaluating Digital Medical Devices (DMDs).…contenu réservé à nos abonnés Premium

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September 27, 2025

End-of-year offers – PREMIUM subscribers: 20% off on MDR online training and exclusive offers on our watch services *.

European Commission: call for evidence on MDR and IVDR

IMDRF: new report on document implementation

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HAS: evaluation principles for Digital Medical Devices (DMD)

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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