On September 28, 2022, the two decrees for the adaptation of Italian regulations to the provisions of MDR (EU) 2017/745 and IVDR (EU) 2017/746 will come into force and apply to all parties involved by the regulations (notified bodies, economic operators and healthcare operators).
The two decrees are specifically Legislative Decrees No. 137 (Medical Devices) and No. 138 (in vitro diagnostic Medical Devices) of August 5, 2022 published in the Gazzetta Ufficiale on September 13, 2022.
As previously anticipated, the measures establish various precepts involving different points of the regulations and having a major impact on the organizational and documentation system of economic operators.
- Language requirements for label and instructions for use: information provided in writing by the manufacturer to the user and patient shall be expressed in Italian at the time of delivery to the end user, for professional use or any other use.
- Distributors’ registration: the distributors are required to register (and confirm the registration every two years at least) in the national database of the Ministry of Health, conferring its data and identifying the devices in Eudamed which they make available on the Italian market.
- Privacy: for the processing of data of a personal nature held or obtained as part of the activities regulated by the decrees (including those of vigilance and post-market surveillance as well as adjustment, calibration, maintenance or assistance, to be carried out even remotely), Legislative Decree 196/2003 on the protection of personal data must be complied with.
- Advertising: the prohibition of advertising to the public for certain types of devices remains (custom-made devices, devices intended for professional use, or those provided on prescription), and the need of a required authorization for such advertising is confirmed as well as the compliance with ministerial guidelines for the advertising targeted to professionals.
- Penalties: the administrative penalty regime provided is diversified and covers non-compliance with regulations, information or promotional communications to the public in violation of Article 7 or advertising regulations, violation of obligations defined for manufacturers, agents, importers and distributors as well as PRRC.
As defined by the Ministry, the decrees also take into account the need to ensure compatibility and constant alignment between national databases and the European Database (Eudamed) in accordance with the Unique UDI Device Identification System and identify appropriate tools to ensure proper management of legacy devices in the transition from directives to regulations.
This will be followed by future measures by the Ministry of Health to define operational procedures for the registration of manufacturers of custom-made devices, methods of reporting incidents by healthcare professionals, maintenance devices’ UDI by healthcare institutions, submission of clinical investigation reports, and definition of the tasks and composition of the National Medical Device Price Observatory.
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