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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

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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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REACh: new restrictions on substances D4, D5 and D6

2025-09-26

[2025-09-17] REACh (Registration, Evaluation, Authorization and restriction of Chemicals) is the European regulation governing the registration, evaluation, authorization and restriction of chemical substances. It applies…contenu réservé à nos abonnés Premium

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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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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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