(“Repertory Number” is a must)
We collect your entire CE documentation in order to submit it to the Italian healthcare Authority and get dedicated Repertory Number that’s a must for public tender purchase in Italy
Medical device Repertory
Access by National Health System professionals Provisions in the 2003 Financial Law (Law 266/2002) provided for the creation of the General Repertory of medical devices marketed in Italy (RDM), in order to allow both economic assessments by public subjects in charge of their procurement or the definition of sector-related policies and the setting of reference prices for devices. (Art. 57, paragraph 1). Moreover, this article established that in order to achieve these aims, the devices should be classified in uniform classes and sub-classes, giving responsibility for this classification to the National Commission for Medical Devices (CUD), which created the National Classification of Medical Devices (CND). It has therefore been necessary to create, in addition to the registration system (a database) of all medical devices, already provided for by legislation in force, another registration system, the Repertory of medical devices not procured by the National Health System.In this circumstance, it has been deemed necessary to include this second tool (the Repertory) within the first (the database), given that it was necessary to gather a subset of information from the wider set of data related to all devices marketed in Italy in order to enable the subjects concerned to register both tools with a single step. Rules regarding procedures for registration with the database and the Repertory have been laid down in the Ministerial Decree of 20 February 2007(pdf, 24 KB). The Repertory is augmented and accessed online only via the Ministry of Health website, by manufacturers or their proxies. At the end of the registration phase, devices are assigned a repertory number to identify them unambiguously in all commercial activities involving the National Health System. Finally it is worth remembering, as a result of Ministerial Decree of 20 March 2007 (pdf,28 KB), that in some cases manufacturers or their proxies can include in the repertory many variants of a device as a single entry, on the basis of evaluation parameters guaranteeing that such products can in any case be considered as a “single device”. In such cases a single repertory number will identify all variants of the device.
