Questions concerning regulations
Could a medical device be concerned by Directives other than those specifically covering medical devices?
How do I determine the class of a medical device?
Are the rules for placing a medical device on the market identical in all European countries?
Is CE marking valid for the world market?
Where can I find the MEDDEV classification guides and the list of harmonized European standards?
How do I choose a subcontractor that meets the requirements of the medical device Directives?
Could a medical device be concerned by Directives other than those specifically covering medical devices?
CE marking for a medical device refers to one of the three specific Directives:
- 90/385/EEC on active implantable medical devices
- 93/42/EEC on medical devices
- 98/79/EC on in vitro diagnostic medical devices
But other Directives may also apply. For example, the Directive on electromagnetic compatibility covers the electromagnetic interference that a medical device may emit or receive.
Similarly, medical devices intended to administer a medicinal substance must also be assessed with regard to the provisions of the Directives covering the medicinal product.
Are the rules for placing a medical device on the market identical in all European countries?
Yes. The “new approach” Directives 90/385/EEC, 93/42/EEC and 98/79/EC aim to provide a common legislative base for all European countries (EU and EFTA).
However, we recommend that you consult the national law in which the Directives are adapted (the Public Health Code in the case of France).
Is CE marking valid for the world market?
No. CE marking is required for the European market only. It is valid in all 32 countries of the European Economic Area (EU plus EFTA). But CE marking may also make it easier to obtain access to other markets, such as Australia, Egypt, Morocco or Turkey.
Where can I find the MEDDEV classification guides and the list of harmonized European standards?
You can download these guides from the European Commission website.
How do I choose a subcontractor that meets the requirements of the medical device Directives?
The interpretations of the Directives states if a subcontractor possesses a quality management system certificate issued by a notified body, it facilitates the granting of CE certificates for the manufacturer of the medical device. If this is not the case, the subcontractor may be audited by the notified body acting for the manufacturer.