In terms of CE Marking a medical device, what directives are concerned?
• 90/385/EEC active implantable medical devices • 93/42/EEC medical devices • 98/79/EC in vitro diagnostic medical devices Depending on the specifics of your product, other specific directives could apply, such as those related to electromagnetic compatibility or those covering substances which are delivered by your device. 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). Is CE Marking valid for the world market? CE Marking is a requirement in more than 30 countries, including all of those in the European Economic Area (EU plus EFTA). While not required in other markets, CE Marking may make it easier to obtain access t
