Do you need to register a medical device in the Italian Repertory?


 

In a few days we can assign a Repertory number to the devices you manufacture and/or distribute


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Legislative Decree 46/97, which transposed European Directive 93/42 on medical devices, provided for the obligation to notify the Ministry of Health of the placing on the market of each medical device, except for a few exceptions of species. By ministerial decree, as from 1 May 2007, this notification must be made by means of new telematic methods. 

The registration obligation concerns the following subjects 

  • manufacturers of medical devices, as defined in Article 1, paragraph 2, letter f) of Legislative Decree no. 46 of 24 February 1997;
  • the subjects referred to in article 12, paragraphs 2 and 3 of legislative decree n. 46 of 24 February 1997;
  • other persons responsible for placing medical devices on the market;
  • subjects validly delegated by the figures referred to in letters a, b, c

The notification of a medical device essentially involves the communication to the Ministry of Health of various technical, regulatory and commercial data, some mandatory and others optional. The compulsory data include the CND class, which allows the medical device to be classified in a given category of product on the basis of a ministerial list. 

At the end of the registration process, a registration number is assigned to the Database or to the Repertory subset. This number, known as the "Directory Number" or "RDM", allows the medical device to be identified regardless of the sales code. 

Within a few days, Eumed can get you a Repertory Number for each medical device you manufacture and/or distribute.