Pilot coordinated assessment for CI/PS

18/03/2025

Member States, supported by the European Commission, are pleased to announce the launch of a pilot coordinated assessment of clinical investigations and performance studies across multiple Member States as per Articles 78 of the Regulation (EU) 2017/745 and 74 of the Regulation (EU) 2017/746 respectively.

Read the news published by Directorate-General for Health and Food Safety on 6 February 2025.

lsgilbert

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OpenEdition vous propose de citer ce billet de la manière suivante :
lsgilbert (18 mars 2025). Pilot coordinated assessment for CI/PS. ELSIBI. Consulté le 7 octobre 2026 à l’adresse https://doi.org/10.58079/13icz

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Étiquettes : Clinical studiesEU RegulationEuropean CommissionIVD Medical DevicesMedical devices

• Article suivant Prior Information Notice – EU4Health call for tenders on the development of a rapid point-of-care antimicrobial susceptibility testing diagnostic medical device
• Article précédent MDCG 2019-6 rev.5 – Questions and answers: Requirements relating to notified bodies (February 2025)

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