MDCG 2023-1 – Guidance on the health institution exception under Article 5(5) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 – January 2023
The provisions in Article 5(5) of the Regulations (EU) 2017/745 and (EU) 2017/746 are the basis for the regulatory control and oversight of in–house devices. The document provides guidance on the application of some of these rules.
Read the news announcement published by EC Directorate-General for Health and Food Safety on 10 January 2023.
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lsgilbert (13 février 2023). MDCG 2023-1 – Guidance on the health institution exception under Article 5(5) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 – January 2023. ELSIBI. Consulté le 18 février 2025 à l’adresse https://doi.org/10.58079/o68f