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

The Medical Devices Directive (93/42/EEC), along with two associated directives (the Active Implantable Medical Devices Directive and the In Vitro Diagnostic 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. The Directive excludes any products which come within the scope of one of the other two medical device directives.

The Medical Devices Directive has a very wide scope and it is important to realize that the intended purpose and the way a product is marketed can cause them to be covered or excluded. The Directive defines and applies different administrative requirements to four classifications of medical device. These classifications are based on the risk a device presents to the public, as defined through a series of classification rules.

The Directive came fully into force in June 1998 and is enforced in the UK by the Medicines and Healthcare products Regulatory Agency (MHRA).

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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