The Electro-medical Equipment (EEC Requirements) Regulations 1988

Made9th September 1988

Laid before Parliament20th September 1988

Coming into force11th October 1988

The Secretary of State, being a Minister designated1 for the purposes of section 2(2) of the European Communities Act 19722 in relation to the sale, free movement or use of electro-medical equipment which conforms to prescribed standards and the reimbursement in respect of services provided with the help of such equipment, in the exercise of powers conferred by that section and of all other powers enabling him in that behalf, hereby makes the following Regulations:

Citation and commencement1

These Regulations may be cited as the Electro-medical Equipment (EEC Requirements) Regulations 1988 and shall come into force on 11th October 1988.

Interpretation2

In these Regulations—

“the Act of 1968” means the Trade Descriptions Act 19683;
“the Directive” means Council Directive 84/539/EEC on the approximation of the laws of the member States relating to electro-medical equipment used in human or veterinary medicine4;
“declaration” means a declaration which conforms with the specimen declaration contained in Annex IV to the Directive;
“electro-medical equipment” means electro-medical equipment listed in Annex II to the Directive which is intended, by its nature, for use in human or veterinary medicine;
“the reversed epsilon” means a mark which conforms with the specimen mark contained in Annex III to the Directive;
“supply” has the same meaning as in section 46 of the Consumer Protection Act 19875 and includes offering to supply, agreeing to supply, exposing for supply and possessing for supply.

Marking3

Where any person supplies electro-medical equipment which is marked with the reversed epsilon (or with a mark so closely resembling it as to be likely to be taken to be the reversed epsilon) or to which a declaration has been applied but that equipment does not comply with the technical requirements contained in Annex I to the Directive that person shall be guilty of an offence.

Application of the Trade Descriptions Act 19684

1

The following provisions of the Act of 1968 shall (with necessary modifications) apply in relation to an offence under these Regulations as they apply in relation to an offence under that Act (modified where appropriate in relation to Northern Ireland by section 40(1) of that Act6), that is to say sections 187, 198, 20, and 24.

2

The following provisions of the Act of 1968 shall (with necessary modifications) apply in relation to the enforcement of these Regulations as they apply in relation to the enforcement of that Act (modified where appropriate in relation to Northern Ireland by section 40(1) of that Act), that is to say sections 269, 27, 2810, 2911 and 30(1).

3

Section 33 of the Act of 1968 (modified in relation to Northern Ireland by section 40(1) of that Act) shall apply in relation to compensation for goods seized and detained under these Regulations as it applies to compensation for goods seized and detained under that Act.

Enforcement of health and safety legislation5

1

In any proceedings against a person for an offence under any of the relevant statutory provisions (as defined by section 53(1) of the Health and Safety at Work etc Act 197412 or, as the case may be, article 2(2) of the Health and Safety at Work (Northern Ireland) Order 197813) which imposes requirements on grounds of safety relating to the manufacture of electro-medical equipment for use at work, it shall be a defence for that person to show that that equipment conforms with the requirements of the Directive.

2

Where an improvement notice or prohibition notice has been served on any person pursuant to section 21 or, as the case may be, section 22 of the Health and Safety at Work etc Act 1974, or articles 23 or 24 of the Health and Safety at Work (Northern Ireland) Order 1978, if the person upon whom the notice was served appeals to an industrial tribunal pursuant to section 24 of the said Act or article 26 of the said Order and shows that the notice refers to grounds of safety relating to the manufacture of electro-medical equipment for use at work which conforms with the requirements of the Directive, the tribunal shall cancel the notice.

K. ClarkeOne of Her Majesty’s Principal Secretaries of State9th September 1988

(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.