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Italy database of medical devices

Registration into the MD and IVD database

The Decree of the Ministry of Health 20 February 2007 has set up the new database of medical devices (MDs), to collect data and information regarding all medical devices marketed in the Italian territory by their manufacturers.

The Italian database is an important instrument for market surveillance, as well as for the supervision of medical devices in the country. This database was set up in response to the requirement of registration of operators and medical devices in compliance with the provisions of Directive 93/42/EEC.

Over the years, the database has been updated and is now able to collect data on kits and in vitro diagnostic medical devices.

Moreover, the database of the Italian Ministry of Health also include a subset called “Repertorio”. The registration of the devices into the Repertorio allows all operators of the Italian National Health Service to view information and documentation relating to these devices.

This feature facilitates manufacturers in tenders, as no additional documentation on the MD concerned by the tender is required from the manufacturer just because it can be found via the Repertorio.

To date, a full implementation of the European database EUDAMED – introduced by the text of Regulation (EU) 2017/745, recently applied, and designed to be accessed by users – is still missing (currently only the first module regarding economic operators is available).

Di Renzo Regulatory Affairs has a special unit dedicated to regulatory activities for MDs and IVDs, and can assist companies in the registration of MDs into both the Italian database and the Repertorio.

Thanks to its international cooperation with several consultants in the EU countries, Di Renzo Regulatory Affairs can also take care of notification procedures in other Member States.

Di Renzo Regulatory Affairs can also assist manufacturers, importers, authorised representatives and assemblers with the service of registration into the first EUDAMED module regarding economic operators, in order to allow the company to obtain the SRN – single registration number.

Foto di Firmbee da Pixabay