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New registration procedure for manufacturers of custom-made medical devices

dispositivi medici su misura

A “custom-made device” means any device specifically made in accordance with a written prescription (…) which gives specific design characteristics, and is intended for the sole use of a particular patient exclusively to meet their individual conditions and needs.

This definition has remained practically unvaried in the transition from Directive EC 93/42 to Regulation 2017/745 EU, however the latter has added a series of compliances for the manufacturers, in particular as far as the post-marketing surveillance of medical devices is concerned.

Currently, manufacturers and authorised representatives of custom-made MDs located in Italy have the obligation to register themselves in a list held by the Ministry of Health, and to transmit the data regarding their custom-made medical devices put on the market.

The purpose of registration

This registration has the purpose of collecting information, ensuring effective control by the Ministry of Health on the MD sector.

The recent publication of the Decree of the Ministry of Health of 9 June 2023 in the Official Journal establishes the procedures to transmit and store the manufacturers’ data and the list of custom-made devices made available on the national territory, according to Regulation (EU) 2017/745.

The Decree provides for transitory provisions for the online registration of the manufacturers already included in the lists of the Ministry of Health.

As provided for by article 7 of Legislative Decree 5 August 2022, no. 137, the data indicated in the registration application must be updated within 30 days in case of change of the data as well as in case of a change in the type of manufactured devices.

In case of cessation of the activity, manufacturers of custom-made devices must also inform the Ministry of Health within 30 days.

As for manufacturers already included in the register, they have 6 months to update their data. Such update can be done online.

Finally, the Decree establishes the time of storage of the data reported. The data of manufacturers of  custom-made implantable devices are stored for a period of fifteen years as of the date of the communication on the cessation of the activity.

For manufacturers of custom-made devices other than implantable devices, the manufactures’ data are stored for a period of ten years as of the of the date of the communication on the cessation of the activity.

Written on 09/14/2023 by Sofia Tabacco

Foto di distinctivedentistry23 da Pixabay