The decrees on medical devices govern aspects of national competence in continuity with the legislative decrees 46/97, 507/92 and 332/2000, establishing among other things the linguistic requirements for the label and for the instructions for use, confirming the obligation of registration for manufacturers of custom-made devices and distributors, providing indications for advertising and online sale of devices, defining criteria for the granting of authorizations in derogation in the event of deficiencies on the market and finally defining a sanctioning system for violations of the conduct provided for in the Regulations.
The decrees take into account the need to ensure the compatibility and constant alignment between the national databases and the European database (Eudamed) in accordance with the single identification system of the UDI device and identify suitable tools to ensure correct management of legacy devices in the transition from directives to regulations.
National decrees reflect the progressive application of European regulations and provide for the possibility, in some cases the burden, on the part of the Ministry of Health to define requirements, criteria and procedures to regulate specific areas.
Subsequent provisions of the Ministry of Health will define operational procedures for the registration of manufacturers of custom-made devices, methods of reporting accidents by health professionals, storage of the UDI of devices by health institutions, presentation of communications relating to clinical investigations, definition of the tasks and composition of the National Observatory for the prices of medical devices.
The decrees also intervene to make procurement procedures more efficient through the articulation and strengthening of the Health Technology Assessment (HTA) functions and the adjustment of the activities of the Observatory on the purchase prices of devices, for a renewed governance of the Medical Devices.
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