Are the rules for selling a medical device in Europe the same in all European countries?
Yes. The “new approach” Directives 90/385/EEC, 93/42/EEC and 98/79/EC provide a common legislative base for all European countries (European Union and European Free Trade Association). However, we recommend that you consult the national law from which the Directives were adapted (e.g., the Public Health Code in the case of France).
