MEDICAL DEVICE

 

Medical device


The community directives and the Italian legislative norms that have transposed them regulate, separately, three categories of medical devices

• active implantable medical devices (Directive 90/385 / EEC; Legislative Decree December 14, 1992, n. 507)
• medical devices (generally), (Directive 93/42 / EEC, Legislative Decree of 24 February 1997, No. 46)
• in vitro diagnostic devices (Directive 98/79 / EC; Legislative Decree 8 September 2000, n.332)

Based on the definition of medical device contained in the legislative decree n. 46 of 1997, which, concerning the generality of devices different from the two categories that have specific regulations (active implantable and in vitro diagnostic), applies to most of the products available on the market a medical device is:
• a device
• a machine
• implant
• a substance
• other product
used alone or in combination, including computer software used for a correct use, and intended by the manufacturer to be used on humans for the purpose of:

• diagnosis, prevention, control, therapy, or mitigation of an illness
• diagnosis, control, therapy, attenuation or compensation of a wound or handicap
• study, replacement or modification of the anatomy or of a physiological process
• intervention on conception

provided that it does not exercise the principal action in or on the human body, to which it is intended, by pharmacological or immunological means, or by metabolic process, but whose function can be assisted by such means.
consulting and Regulatory fee online : ISO 13485:16 (Quality Management System, Requirements to documentation, Liability requirements, Requirements to Resource Management, Design and Production, Measurements analysis and improvement