Home » Custom-made medical devices, the deadlines for registration in the new lists of manufacturers already registered have been extended

Custom-made medical devices, the deadlines for registration in the new lists of manufacturers already registered have been extended

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Custom-made medical devices, the deadlines for registration in the new lists of manufacturers already registered have been extended

The Decree of the Minister of Health of 9 June 2023 established that starting from 1 September 2023 the information regarding the manufacturer’s identification data and the list of types of customized medical devices made available on the national territory in accordance with the regulation (EU ) 2017/745, must be provided exclusively through electronic communication networks.

The same decree provided for a further period of six months to allow the transition of manufacturers already registered pursuant to Legislative Decree 46/97 or pursuant to Regulation (EU) 2017/745 with the use of pre-existing methods.

Considering that the new online service was activated starting from 25 September 2023, based on requests from some trade associations, which expressed the need for additional time to complete the transition to the new system, the date initially foreseen was extended to May 1, 2024.

After this date, therefore starting from 2 May 2024, the pre-existing lists relating to manufacturers of custom-made medical devices will no longer be available for consultation on the institutional website of the Ministry of Health.

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