During last 5 May preliminary hearing, the Council of Ministers approved the draft of the Legislative Decree adjusting the national legal framework to MDR (UE) 2017/745 and IVDR (UE) 2017/746.
As defined by article 15 of Enabling Act No. 53 of 21 April 2021, this decree implements and adopts within the legal system the regulations’ general principles for certain regulatory aspects of interest, from clinical investigations to post-marketing surveillance, vigilance and market surveillance activities.
Although not yet approved, it is useful to anticipate some of the issues highlighted by the decree.
Advertising: controls according to Article 7
The advertising prohibition remains for custom-made and prescription Medical Devices (devices for professional use).
For other devices, on the other hand, the requirement for prior authorisation for advertising remains, which is issued following the procedure currently foreseen by the Competent Authority but considering the additional requirements set out in Article 7 MDR (EU) 2017/745 and IVDR (EU) 2017/746.
The latter is an important element considering that an analysis of the adequacy of the content of the manufacturer’s declarations will be carried out, in terms of the declared intended use and actual performance of the device.
For regulating advertising to healthcare professionals, on the other hand, nothing has been defined, but the Ministry will publish future guidelines to regulate the process.
Eudamed and national database
Among the Decree’s prescriptions concerning Eudamed and the national database already set up by the Italian Ministry of Health as the Competent Authority to supervise devices placed on the market in the territory are:
- The Ministry of Health may introduce a fee to be paid by the manufacturer, authorized representative, importer for registration procedures in Eudamed.
- Distributors who market devices on national territory, which until now were not required to register in the national database, will have to fulfil this obligation.
- Companies, in the case of role competition, will have to register in Eudamed as manufacturers and in the national database as distributors.
- All entities wishing to make their products available to the National Health Service must register them in the national database by entering their organisation and device data, including the UDI code.
Penalty system: what will change
Among the precepts to be considered with the approval of the draft Decree Law, of great impact is the replacement of the sanctioning regime under the previous directives with a new system adapted to the new and more extensive obligations introduced by the regulations.
In general, for all Economic Operators charged with regulatory obligations (including importers and distributors), the sanctions to be defined will be effective, dissuasive and proportionate to the seriousness of the violations, but above all the sanctions will be reduced where the violation is committed by micro-enterprises, according to Commission Recommendation 2003/361/EC.
The draft still has to pass through the State-Regions Conference and the Committees of the Chamber of Deputies and the Senate (where it may be subject to some modifications) before it goes to final approval.
Through our strategic-regulatory consulting services, Thema professionals can support you in fulfilling the requirements of the Medical Device Regulation MDR (EU) 2017/745 and In Vitro Diagnostic Devices IVDR (EU) 2017/746.
Contact our Customer Service for more information!