On October 26, 2023, the Italian Ministry of Health published an article on its official website on the page Banca dati nazionale dei Dispositivi Medici, aggiornamenti. This informs that from the same date, it is possible to enter the National Database of Medical Devices the information related to both the changes introduced by Regulation (EU) 2023/607 and that related to systems and procedure packs (Art. 22, paragraphs 1 and 2 of Regulation (EU) 2017/745).
As we know, since last March 2023, the medical device sector has started to go through a new transitional period. Certain provisions indicated in Regulation (EU) 2017/745 (MDR), such as the registration of economic operators and the registration of Medical Devices, although mandatory from the date of application of the regulation, cannot be fulfilled in the manner provided for in the European regulations until the Medical Device Database, Eudamed, is fully operational. In this context, registration obligations in Italy are fulfilled by entering the information in the national database. Specifically, all Medical Devices, regardless of their risk class, must be registered with the Italian National Database.
Concerning the entry of information on the changes introduced by Regulation (EU) 2023/607, for devices certified according to the directives, the validity of the EC certificates will be determined based on the indications of Regulation (EU) 2023/607 and the expiry date of the certificates will be automatically updated by the system.
In particular, Regulation 2023/607 stipulates that Medical Devices with an EC Declaration of Conformity AIMDD or MDD, issued before May 26, 2021, and not yet expired, are valid with the following dates:
- For Class III Medical Devices and Class IIb implantable devices, the transitional period is extended from May 26, 2024 until December 31, 2027;
- For Class IIb devices, other than those in the previous paragraph, and Class IIa, Im, Is and Ir devices, the transitional period is extended until December 31, 2028;
- For custom-made implantable class III devices with a request for conformity assessment by the manufacturer made before May 26, 2024, the transition period is extended until May 26, 2026.
In addition, for CE-marked Class I Medical Devices under Directive 93/42/EEC, for which the conformity assessment procedure under Regulation (EU) 2017/745 provides for the involvement of a Notified Body, the system will allow for the selection of several options, based on which the final date for placing the device on the market will be automatically determined.
Finally, to register systems and procedure packs, it is necessary to indicate the information required by Regulation (EU) 2017/745 and, in the case of systems and procedure packs sterilised before being placed on the market (Art. 22(3)), the relevant certificate issued by the Notified Body must also be included.
>> Thema can support you in the registration of Medical Devices and IVDs in the Database of the Italian Ministry of Health, and other Member States whose regulations provide for registration and in EUDAMED.
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