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MDCG 2024-15 – Guidance on the publication of the clinical investigation reports and their summaries in the absence of EUDAMED (November 2024)

Article 77(5) Medical Devices Regulation requires that the sponsor submits to the Member States in which a clinical investigation was conducted a clinical investigation report within one year of the end of the clinical investigation or within three months of the early termination or temporary halt, irrespective of the outcome of the clinical investigation. Furthermore, the clinical investigation report shall be accompanied by a summary presented in terms that are easily understandable to the intended user.

Read the news announcement published by Directorate-General for Health and Food Safety on 2 December 2024.


OpenEdition vous propose de citer ce billet de la manière suivante :
lsgilbert (12 janvier 2025). MDCG 2024-15 – Guidance on the publication of the clinical investigation reports and their summaries in the absence of EUDAMED (November 2024). ELSIBI. Consulté le 25 avril 2025 à l’adresse https://doi.org/10.58079/132eg


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