Implementation of the Medical Device Directive in Italy.
The implementation of the European medical devices Directives by Member States is introducing a significant regulatory uniformity to the European regulation of medical devices. However, Member States are not required to implement the Directives in an identical manner. As a result, it is important to be aware of national variations. This article will discuss the implementation of the Medical Device Directive in Italy.
Donawa
M E
ME
Donawa and Associates Ltd, Rome, Italy. donawa@srd.it
D004389:Durable Medical Equipment / Q000592:standards*; D004867:Equipment Design / Q000592:standards; D004869:Equipment Safety / Q000592:standards*; D019983:Guideline Adherence; D006801:Humans; D007558:Italy; D011356:Product Labeling / Q000331:legislation & jurisprudence* / Q000592:standards