The Medical Devices Regulations 1994

Amendment of the Electro-medical Equipment (EEC Requirements) Regulations 1988

27.—(1) The Electro-medical Equipment (EEC Requirements) Regulations 1988(1) shall be amended in accordance with the following provisions of this regulation.

(2) In regulation 2 (interpretation)—

(a) for the definition of “the Directive” there shall be substituted the following definition—

““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 veterinary medicine(2);”;

(b) in the definition of “electro-medical equipment” the words “human or” shall be omitted.

(3) For regulation 3 (marking) there shall be substituted the following regulation—

“3.   A person shall be guilty of an offence where he supplies electro-medical equipment—

(a) which does not comply with the technical requirements contained in Annex I to the Directive; and

(i) which is marked with the reversed epsilon, (or with a mark so closely resembling it as to be taken to be the reversed epsilon), or

(ii) to which a declaration has been applied; or

(b) which is also a medical device for the purposes of the Medical Devices Regulations 1994(3) and which does not satisfy the essential requirements for that device specified in those Regulations.”.

(1)

S.I. 1988/1586.

(2)

OJ No. L 300, 19.11.84, p. 179, as amended by Council Directive 93/42/EEC (OJ No. L 169, 12.7.93, p. 1).

(3)

S.I. 1994/3017.