The following information is a summary of the requirements of the Directive.
 It is not an area in which we currently offer advice but you may find some useful information and links here.

Summary

This directive applies only to active implantable devices. To be classed as such a device must rely on a power source not provided by the body or gravity and be designed to be introduced into the body with the intention to remain there following the procedure. The Directive specifies that these products should meet essential safety requirements in terms of function, sterility, material compatibility, marking, user instructions and design documentation. In addition there are requirements for type approval, production quality management, clinical investigation and manufacturer registration. The Directive came into force in 1993 and all equipment within the scope must comply.

Amendments to the Active Implantable Medical Devices directive (2007/47/EC) came into force on 21 March 2010.

See also:

Conformance is Trading Globally

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Conformance Offices

Head Office

Great Hucklow
Buxton
Derbyshire
SK17 8RG
United Kingdom

Tel: +44 (0)1298 873800
Fax: +44 (0)1298 873801
E-mail: cemark[at]conformance.co.uk

Lancaster

2 Lodge Cottages
Thurnham
Lancaster
LA2 0DT
United Kingdom

Tel: +44 (0)1298 873800

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