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:
The three decrees have been amended with the Law Decree 25 gennaio 2010, n.37 that is the national implementation of the new EU directive 2007/47/CE, amending directives 90/385/CE, 93/42/CEE, and 98/8/CE. Dir. 2007/47/EC came into force on March, 21st 2010. The full texts of the amended decrees are available at the following links:
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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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