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Regulatory framework

Regulatory framework

Current Legislation

Ranging from simple sticking plasters and contact lenses to sophisticated pacemakers and hip replacements, medical devices and in vitro diagnostic medical devices are important to our health and quality of life. People rely on these devices every day and expect them to be safe and incorporate the latest progress in science and innovation.

Medical devices within the EU are currently regulated by the following 3 directives:

Implementing Measures

The Commission has adopted several implementing measures based on the Medical Devices Directives. These measures concern, among others, medical devices manufactured using tissues of animal origin, the classification of certain medical devices and Common Technical Specifications for In vitro diagnostics (IVDs)s, listed in Annex Ⅱof the IVD Directive.

See key documents on recommendations, classification and other amending and implementing legislation below:

Guidance

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.

Please 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 the revisions page for more information.

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