The requirements in Europe for medical devices can be found in Directives 90/385/EEC and 93/42/EEC. I am not familiar with them but believe that there is no provision for a Suppliers' Decalaration of Conformity in those Directives because in the MRAs on the topic there is talk about all sorts of comparitive exercizes having to do with the work of 3rd Party Testing and Certification organizations, as well as talk about Quality Systems assessments. That does not sound to me like Suppliers Declaration of Conformity. However, I may be wrong.
Ciao, Vic Boersma
