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Explanatory note

Original text. Later amendments are not shown.

(This note is not part of the Regulations)

These Regulations implement Council Directive No. 84/539/EEC relating to electro-medical equipment which is intended, by its nature, for use in human or veterinary medicine.

Regulation 3 makes it an offence to apply the reversed epsilon mark or the declaration described in the Directive to electro-medical equipment which does not conform with the requirements of the Directive.

Regulation 4 applies provisions of the Trade Descriptions Act 1968 to that offence and to the enforcement of, and compensation for goods seized under, these Regulations.

Regulation 5 provides defences where certain proceedings are brought under the Health and Safety at Work etc Act 1974 or the Health and Safety at Work (Northern Ireland) Order 1978 in respect of the use or intended use at work of electro-medical equipment which conforms with the requirements of the Directive.