EC directives define the "essential requirements", e.g., protection of health and safety that products must meet when they are brought to market.

 

Medical devices are regulated by three main directives:

Medical Devices and Combined Products Classified as Devices:
The Medical Device Directive
Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
and related harmonized standards http://ec.europa.eu/enterprise/newapproach/standardization/harmstds/reflist/meddevic.html

Active Implantable Medical Devices
Council Directive 90/385/EEC on Active Implantable Medical Devices (AIMDD) (1990).
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31990L0385:EN:HTML
and related harmonized  standards http://ec.europa.eu/enterprise/newapproach/standardization/harmstds/reflist/implmedd.html 

In Vitro Diagnostic Medical Devices
Council Directive 98/79/EC on In Vitro Diagnostic Medical Devices (IVDMD) (1998). http://ec.europa.eu/enterprise/newapproach/standardization/harmstds/reflist/invimedd.html
and related harmonized standards http://ec.europa.eu/enterprise/newapproach/standardization/harmstds/reflist/invimedd.html