Regulation 27 Amendment of the Electro-medical Equipment (EEC Requirements) Regulations 1988
The Electro-medical Equipment (EEC Requirements) Regulations 1988f1 shall be amended in accordance with the following provisions of this regulation.
In regulation 2 (interpretation)—
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 medicinef2;”;
in the definition of “electro-medical equipment” the words “human or” shall be omitted.
For regulation 3 (marking) there shall be substituted the following regulation—
“3A 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 1994f3 and which does not satisfy the essential requirements for that device specified in those Regulations.”.