There are three European Directives for medical devices, namely the Medical Device Directive 93/42/EEC (MDD), the In Vitro Diagnostic Directive 98/79/EC (IVDD), or the Active Implantable Medical Device Directive 90/385/EEC (AIMDD). Each inclues a definition of the type of device within the scope of the legislation, so before embarking on a program of compliance, it is important to determine whether or not your product is included within one of these definitions.
 
 
The medical device directives include their own requirements for such aspects as electromagnetic compatibility and electrical safety, so compliance with the separate EU directives on these subjects is not required if the products fall within the above definitions.
 
 
There are, however, products that fall in the 'grey' area on the borderlines between the medical devices directives and also between these directives and other European regulatory texts, such as the Medicinal Products Directive (2001/83/EC). Such borderline issues are dealt with by official European Commission guidance MEDDEV 2.14/1 rev.2, and more recent general borderline decisions, available from here.
 
 
If you have questions or concerns regarding with which directive your products need to comply, GEMAR can help - contact us for further information.