What is meant by a Medical Device and what must it comply with? It is necessary to put in place a set of procedures that comply with the essential requirements set out by Legislative Decree No. 46/97 of 24 February 1997, which incorporated Directive 93/42/CEE.
The medical devices are divided into four classes (Class I, IIa, IIb and III) depending on their intended use, according to the classification rules set out by Annex IX of Legislative Decree No. 46/97.
MD are grouped depending on their complexity and potential risk for the patient. The classification is carried out in consideration of the invasiveness of the device, its reliance on an energy source (active device) and the length of time it is in contact with the body. Class I devices present minor risks in terms of safety, Class III devices present greater risks.