# The Medical Devices Regulations 1994, Regulation 27: Amendment of the Electro-medical Equipment (EEC Requirements) Regulations 1988


(1) The Electro-medical Equipment (EEC Requirements) Regulations 1988 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;”;
(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 and which does not satisfy the essential requirements for that device specified in those Regulations.”.

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Source: https://www.legislation.gov.uk/uksi/1994/3017/regulation/27 (the official version)
Page: https://openlegislation.uk/medical-devices-regulations-1994/regulation-27
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.