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Custom medical devices, registration of manufacturers

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Custom medical devices, registration of manufacturers

Published in the Official Gazette the Decree of the Minister of Health of 9 June 2023 which identifies the procedures for providing information regarding identification data of the manufacturer and the list of kinds of custom made medical devices made available on the national territory, pursuant to Regulation (EU) 2017/745.

The decree provides that the registration of manufacturers of custom-made medical devices in the list of the Ministry of Health takes place exclusively online.

The methods of communication of the information are established, pursuant to article 7 of the legislative decree 5 August 2022, n. 137, relating to the identification data of the manufacturer and the list of types of custom-made medical devices that manufacturers make available on the national territory. The decree also establishes the retention times of the manufacturer’s personal data.

The decree provides transitional provisions for online registration of already registered manufacturers in the existing lists of the Ministry of Health.

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