Divisione Medical Devices - Di Renzo Regulatory Affairs
The new registration and communication modalities of the data regarding medical devices are provided by the Ministerial Decree of the 20TH of February 2007. The notification of the medical devices is effected through the web and can be carried out by the manufacturers, by the manufacturer's authorized representative, or by other subjects delegated by the manufacturer.
RegulationItaly has adopted the 3 main European Directives on medical devices via the following laws:
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Medical DevicesAccording to the definition given by the Legislative Decree n. 46 of 1997, medical device means any instrument, apparatus, appliance, material or other article, whether used alone or in combination (including the software used for a correct functioning).
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