The Italian MDR/IVDR implementation decrees will come into force on September 28.
The Italian implementation decrees for Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) will come into force on September 28, 2022. These decrees will apply to all parties involved (notified bodies, economic operators and healthcare operators).
Legislative Decrees no. 137 and 138
The two decrees are specifically Legislative Decrees No. 137 (MDs) and No. 138 (IVDs) of August 5, 2022, published in the Official Gazette on September 13.
Aims of the decrees
These decrees aim to:
re-order the mechanism for setting expenditure ceilings;
define the penalty system;
identify methods for medical device traceability through the reorganization and connection of existing databases in accordance with the Unique Device Identification System (UDI system);
make purchasing procedures more efficient through the definition and strengthening of Health Technology Assessment (HTA) functions and adaptation of the activities of the Device Purchase Prices Observatory.
The prescriptions concerning Eudamed and the national database set up by the Italian Ministry of Health to supervise devices that are marketed in the territory include:
The Ministry of Health may introduce a fee to be paid by the manufacturer, authorized representative, or importer for registration in Eudamed.
Distributors who market devices on the 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 (SSN) must register them in the national database by entering their organisation and device data, including the UDI code.
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