S.I. No. 90/1988:

EUROPEAN COMMUNITIES (ELECTRO--MEDICAL EQUIPMENT USED IN HUMAN OR VETERINARY MEDICINE) REGULATIONS, 1988.

EUROPEAN COMMUNITIES (ELECTRO--MEDICAL EQUIPMENT USED IN HUMAN OR VETERINARY MEDICINE) REGULATIONS, 1988.

I, ALBERT REYNOLDS, Minister for Industry and Commerce, in exercise of the powers conferred on me by Section 3 of the European Communities Act, 1972 (No. 27 of 1972), and for the purposes of giving effect to Council Directive No. 84/539/EEC of 17 September, 1984⁽¹⁾, hereby make the following Regulations:

⁽¹⁾O.J. No. L300/179, 19.11.1984.

1. (1) These Regulations may be cited as the European Communities (Electro-Medical Equipment used in Human or Veterinary Medicine) Regulations, 1988.

(2) These Regulations shall come into operation on the 3rd day of August, 1988.

2. (1) In these Regulations--

"authorised officer" means a person who is--

( a ) an officer of the Minister, or

( b ) a person designated by the responsible authority for the purpose of these Regulations, and appointed in writing by the Minister to be an authorised officer for the purposes of these Regulations;

"the Council Directive" means Council Directive No. 84/539/EEC of 17 September, 1984 ⁽¹⁾;

"the Minister" means the Minister for Industry and Commerce;

"the responsible authority" means EOLAS -- the Irish Science and Technology Agency.

(2) A word of expression that is used in these Regulations and is also used in the Council Directive has, unless the contrary intention appears, the meaning in these Regulations that it has in the Council Directive.

3. These Regulations apply to the electro-medical equipment listed in Annex II to the Council Directive which is intended, by its nature, for use in human or veterinary medicine.

4. A person shall not manufacture equipment to which these Regulations apply for sale in a Member State of the European Economic Community unless--

( a ) the equipment conforms with the technical requirements set out in Annex I to the Council Directive, and

( b ) the equipment--

(i) bears a mark which conforms to the specimen shown in Annex III to the Council Directive, or

(ii) is accompanied by a declaration which conforms to the specimen shown in Annex IV to the Council Directive.

5. A person shall not import into the State, sell or offer for sale, equipment to which these Regulations apply unless--

( a ) the equipment conforms with the technical requirements set out in Annex I to the Council Directive, and

( b ) the equipment--

(i) bears a mark which conforms to the specimen shown in Annex III to the Council Directive, or

(ii) is accompanied by a declaration which conforms to the specimen shown in Annex IV to the Council Directive.

6. (1) The Minister may appoint persons to be authorised officers for the purposes of these Regulations and may revoke any such appointment.

(2) Notice of an appointment and the revocation of an appointment shall be published in the Iris Oifgiúil.

(3) An authorised officer shall be furnished with a certificate of his appointment and when visiting any premises to which the provisions of these Regulations apply shall, if so required, produce a certificate to the occupier or any other person holding a responsible position of management at the premises.

7. An authorised officer may at all reasonable times enter any premises, ship, aircraft, vehicle, railway wagon or vessel in which he has reasonable grounds for believing that equipment to which these Regulations apply are being manufactured, kept, sold or prepared for sale or is being transported for sale, and there or at any other place--

( a ) inspect and take copies of or extracts from any books, records or other documents which he finds in the course of his inspection, and

( b ) make such examinations, tests and inspections, as he considers appropriate for the purposes of the Regulations.

8. a person in charge of any premises, or a ship, aircraft, vehicle, railway wagon or vessel, and any person employed in connection therewith, shall--

( a ) afford to an authorised officer such facilities and assistance as are reasonably necessary to enable the officer to perform his functions under these Regulations,

( b ) produce to an authorised officer any books, documents or other records which are in that persons power or control and to give to him such information as he may reasonably require in regard to any entries in such books, documents or records,

( c ) give to an authorised officer any other information which he may reasonably require.

9. A person who obstructs or interferes with an authorised officer in the course of exercising a power conferred on him by these Regulations or fails or refuses to comply with a request made by, or to answer a question asked by, an authorised officer pursuant to these Regulations shall be guilty of an offence.

10. (1) The Minister may, on the basis of a substantiated justification submitted to him provisionally prohibit the sale, free movement or use of any electro-medical equipment listed in Annex II to the Council Directive where he is of the opinion that the equipment, although complying with the requirements of the Council Directive, represents a hazard to safety.

(2) A person shall not sell or have in his possession for sale or offer for sale electro-medical equipment the sale, free movement or use thereof is prohibited by the Minister.

11. A person who contravenes a provision of these Regulations shall be guilty of an offence and shall be liable on summary conviction thereof to a fine not exceeding £1,000.

12. Where an offence under these Regulations is committed by a body corporate and the offence is proved to have been committed with the consent of, or connivance of, or to be attributable to any neglect on the part of any Director, Manager, Secretary or other officer of the body or any person who was purporting to act in any such capacity, he, as well as the body, shall be guilty of the offence and shall be liable to be proceeded against and punished accordingly.

13. An offence under these Regulations may be prosecuted by the Minister or the Minister for Health.

GIVEN under my Official Seal, this 3rd day of May, 1988.

ALBERT REYNOLDS,

Minister for Industry and Commerce.

EXPLANATORY NOTE

The purpose of these Regulations is to give legal effect to 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 medicine.

These Regulations prohibit the manufacture, importation, sale or offer for sale of certain electro-medical equipment unless the requirements of the Directive are complied with.