Italy: Registration of manufacturers of custom-made devices

In brief

On 4 September 2023, the Decree of the Minister of Health dated 9 June 2023 on "Procedures for submitting information on the manufacturer's identification data and the list of types of custom-made devices made available on the national territory" was published in the Official Gazette.


Key takeaways 

The Decree establishes the procedures pursuant to which manufacturers of custom-made devices shall submit to the Ministry of Health the data and information referred to in Article 7 of Legislative Decree No. 137 of 2022, amongst which, the manufacturer's identification data, the list of devices made available on the national territory, changes related to the aforementioned identification data or types of devices and the cessation of activities.

The Decree also provides that, following the fulfillment of their communication obligations, manufacturers of custom-made devices will be registered in a special list managed by the Ministry of Health and also identifies the retention periods for manufacturers' personal data, whose duration depends on whether the devices placed on the market are implantable or not.

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