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 representatives, or by other subjects delegated by the manufacturer. [+]
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According to the definition given by the Legislative Decree n. 46 of 1997, medical devices means any instrument, apparatus, appliance, material or other article, whether used alone or in combination (including the software used for a correct functioning) [+]
Di Renzo Regulatory Affairs carries out, by proxy from the manufacturer, the registration in the data bank and in the listing according to the modalities expected by the Decree of the Ministry of Health of the 20th of February 2007
We provide qualified technical assistance throughout the entire notification process. [+]
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