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), and 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.
 
 
Some products may fall within ‘grey’ areas on the boundaries of the scope of one of the medical device directives and another directive, for instance devices which incorporate pharmaceuticals, or items that have dual intended purposes, e.g. potentially falling within both the MDD and the Personal Protective Equipment (PPE) Directive (89/686/EEC); or the MDD and the Machinery Directive (2006/42/EC). In addition the Directive on the restriction of hazardous substances (RoHS2) is also a CE marking directive which applies to medical devices.
 
 
For further information on the CE marking of IVDs, please refer to the section of our website dedicated to in vitro diagnostic devices.
 
 
If you have questions or concerns regarding with which directive your products need to comply, GEMAR can help - contact us for further information.