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Registration of medical devices in the database of the Italian Ministry of Health

Registration of medical devices in the database of the Italian Ministry of Health

As established by the Ministry Decree 21 December 2009, Changes and integrations to decree 20 February 2007 laying down the New methods for the compliance provided for by article 13 of legislative decree 24 February 1997, no. 46 as amended, as of 1st May 2007 the obligation to proceed with the registration into the Italian medical device database became effective.

The registration obligation concerns the following subjects:

  • manufacturers of medical devices, as defined under article 1.2.f of legislative decree 24 February 1997, no. 46;
  • subjects as per article 12.2 and 12.3 of legislative decree 24 February 1997, no. 46, procedure pack producers;
  • other subjects responsible for placing medical devices on the market;
  • subjects effectively delegated by the roles as per letters a, b, c.

The registration obligation according to the new methods concerns medical devices marketed in Italy for the first time as of 1st May 2007, in details:

  • class I, IIa, IIb and III medical devices
  • systems and  procedure packs as per article 12 of leg.dec. 46/1997
  • active implantable devices.

The access to the banca database and to the Repertorio (catalogue) according to the methods provided for as of 1st May 2007 has been distinguished according to two functional pathways for the companies operating directly in the database and in the Repertorio.

In fact, if the operating company acting as one of the roles provided for by the norms (Manufacturers/Authorised Representative/Other subject delegated by the Manufacturer) have their headquarters on the Italian territory, they shall proceed to the registration via the “Portale delle Imprese” (business portal).

If, on the other hand, the operating company acting as one of the roles provided for by the norms (Manufacturers/Authorised Representative/Other subject delegated by the Manufacturer) have no headquarters on the Italian territory, they can proceed to the registration via the “Nuovo Sistema Informativo Sanitario” (New Health Information System, NSIS).

Custom-made devices and in vitro diagnostics are excluded; for these there are  different methods  in place. Medical devices intended for clinical trials are also excluded.

Medical device registration consultancy in Italy

The medical device “Repertorio”

The “Repertorio” (catalogue), instituted by decree 20 February 2007, is a subset of the database where medical devices can be voluntarily registered to make them more visible to the facilities of the Italian National Health System as well as to the Italian regions.

With the registration into the Repertorio, the latter will have access to the full set of information and documents uploaded into the database by the declarant upon notification. Actually, it should be reminded that the public section of the Ministry of Health database only shows a minimum set of information.

The registration into the Repertorio is usually requested only during tenders and it is useful for suppliers to avoid the submission of the whole set of documents in hard copy for devices or procedure packs.

Registration of medical devices complying with Regulation (EU) 2017/745

While waiting for  EUDAMED be fully operative (the medical device European database), the Ministry of Health has clarified that the registrations into the national databases already provided for leg.dec. 46/1997 should be continued.

The Italian Competent Authority has specified the above in the second section of the memorandum letter dated 12 November 2021.

In fact, after appropriate technical adjustments, the database now also collects information regarding medical devices complying Regulation (EU) 2017/745.

Adoption of Regulation (EU) 607/2023

The Italian Ministry of Health database has been further updated following the entering into force of Reg. (EU) 607/2023.

In fact, as of 26 October 2023 it is possible:

  • to include information regarding systems and procedure packs declaring their actual compliance with art. 22.1 and 22.2 of Regulation (EU) 2017/745;
  • to upload documents and include information required for medical devices enjoying the official extension of the transition period as per Reg. (EU) 607/2023.

Written on 16/07/2024 by Riccardo Del Signore