Ranging from simple sticking plasters and contact lenses to sophisticated pacemakers and artificial hearts, medical devices and in vitro diagnostic medical devices are important to our health and quality of life. People rely on these devices every day. They expect them to be safe and to incorporate the latest progress in science and innovation.
Medical devices within the EU are currently regulated by 3 directives:
Council Directive 90/385/EEC on Active Implantable Medical Devices (AIMDD) (1990)
Council Directive 93/42/EEC on Medical Devices (MDD) (1993)
Council Directive 98/79/EC on in vitro Diagnostic Medical Devices (IVDMD) (1998)
The Commission has adopted several implementing measures based on the medical devices directives. These measures concern, among other things, medical devices manufactured using tissues of animal origin, the classification of certain medical devices, and common technical specifications for in vitro diagnostic devices (IVDs), listed in annex II of the IVD directive.
Below are links to key documents on recommendations, classification and other amending and implementing legislation
In addition, legally non-binding guidance documents: MEDDEVs, consensus statements and informative documents pursue the objective of ensuring uniform application of the relevant provisions of the directives within the EU. Note that all guidance and implementing measures under the current Directives will be reviewed over the next few years in the light of the texts of the 2 new regulations. See new regulations and guidance for new regulations for more information.