Legislative Decree n. 137 of August 5, 2022 adapting Italian legislation to the MDR has been published on September 13; the decree will be in force starting from September 28, 2022. Legislative decree n. 138/2022 issues similar provisions in relation to the IVDR.
The main provisions of Legislative Decree n. 137 on medical devices are summarized here:
- Competent Authority: unsurprisingly, the Italian Ministry of Health has been designated as competent authority pursuant to Section 101 of the MDR and responsible authority for notified bodies. The Italian Ministry of Health will be in charge of:
- Resolving disputes arisen between manufacturers and notified bodies;
- Authorizing the sale of medical devices, which have not achieved full compliance, in cases of urgency and for public health or patients’ needs;
- Verifying the information rendered by manufacturers, agents and importers on Eudamed, and releasing the unique registration number;
- Surveillance activities on the implementation of the MDR;
- Receiving incident reports;
- Reporting of falsified devices.
- Custom-made medical devices: manufacturers of custom-made medical devices must notify the Ministry of Health their identifying information and the list of said devices.
- Clinical Investigations: no clinical investigation can be started without notification to the Ministry of Health. However, for Class III and invasive class IIa and IIb medical devices, clinical investigations may begin only after obtaining ministerial authorization.
- HTA: Health Technology Assessment is promoted.
- Remote selling of medical devices: in case a website is detected as a promoter of illegal practices, the Ministry of Health may issue measures in order to prevent access to the website.
- Advertisement: advertisement to the public of medical devices that (i) are custom-made, (ii) for which assistance by a healthcare professional is mandatory in accordance with applicable laws or with the manufacturer’s instructions, or (iii) require a prescription, is prohibited. Devices that are different from the foregoing may be advertised following authorization by the Ministry of Health. The Ministry of Health will issue specific decrees and guidelines on advertisement.
- Sanctions: several sanctions have been introduced (generally up to Euro 145,000).
- Medical Device Governance Fund: companies that manufacture or sell medical devices will have to disburse an annual fee equal to 0.75% of turnover, net of value-added tax, from the sale of medical devices and large equipment to the National Health Service to the fund. One third of the resources of the fund will be allocated to HTA activities.
While the decree helps aligning Italian law with the MDR, many more rules will need to be issued are delegated to the Ministry of Health and thus grey areas continue to exist.