Notified body consensus statements.
The ability of governments, official bodies, industry and others to uniformly interpret the European Directives for medical devices will have a profound effect on the success of the European system regulating these products. This is particularly important for Notified Bodies. This article will discuss Notified Body consensus statements. An article in the near future will discuss Notified Body recommendations.
Donawa
M
M
Donawa and Associates Ltd, Rome, Italy. donawa@srd.it
D002568:Certification; D004864:Equipment and Supplies / Q000592:standards*; D005060:Europe; D017408:Guidelines as Topic