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

[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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Proposed simplification of MDR and IVDR

[2025-12-16] (Open access) The European Commission adopted on December 17, 2025 a proposal to simplify regulations (EU) 2017/745 for medical devices (MDR) and (EU) 2017/746 for in vitro diagnostic medical devices (IVDR). Expected like the Messiah by the entire industry...

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

[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 <div id="load" style="border: 2px solid #000; padding: 25px; font-size: 20px;...

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

[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 <div id="load" style="border: 2px solid #000; padding: 25px; font-size: 20px;...

Malaysia becomes an affiliate member of MDSAP

[2025-09-19] (Open Access) Malaysia’s Medical Device Authority (MDA) announced its recognition as an affiliate member of the Medical Device Single Audit Programme(MDSAP) via its website on September 19, 2025. For the record: The MDSAP is a unique audit program designed...