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, along with two associated directives, the Medical Devices Directive and the Active Implantable Medical Devices Directive, cover all medical equipment. This directive includes equipment intended by the manufacturer to be used to diagnose, prevent, monitor, treat, alleviate, compensate for and/or control a disease, injury, handicap, physiological process or conception.

This directive excludes any products which come under the scope of one of the other two medical directives. This particular directive covers equipment used in laboratories and not in the patient environment. The directive came fully into force in June 2000 and is enforced in the UK by the Medicines and Healthcare Products Regulatory Agency (MHRA).

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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