The Active Implantable Medical Devices (Amendment and Transitional Provisions) Regulations 1995

Amendment of regulation 2(1) of the principal Regulations

2.—(1) Regulation 2(1) of the principal Regulations (interpretation) shall be amended in accordance with the following provisions of this regulation.

(2) In the definition of “authorised representative” the words “European Economic” shall be omitted.

(3) The definition of “EC mark” shall be omitted and after the definition of “authorised representative” there shall be inserted the following definitions—

““CE marking” means the marking which indicates that one or more of the procedures referred to in regulation 5 has, or as the case may be, have been followed and which complies with the provisions of Schedule 1;

“the Community” means the European Economic Area established under the EEA Agreement;”.

(4) After the definition of “the Directive” there shall be inserted the following definition—

““the EEA Agreement” means the Agreement on the European Economic Area signed at Oporto on 2nd May 1992 as adjusted by the Protocol signed at Brussels on 17th March 1993;”.

(5) In the definition of “harmonised Standard” for the words “Commission of the European Economic Community” there shall be substituted the words “European Commission”.

(6) After the definition of “intended purpose” there shall be inserted the following definition—

““manufacturer” means the person who is responsible for the design, manufacture, packaging and labelling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party;”.

(7) For the definition of “member State” there shall be substituted the following definition—

““member State” means a State which is a Contracting Party to the EEA Agreement;”.

(8) For the definition of “placed on the market” there shall be substituted the following definition—

• ““placing on the market” means, in relation to a device, the first making available in return for payment or free of charge of a new or fully refurbished device other than a device intended for clinical investigation, with a view to distribution, use, or both, on the Community market;”.

(9) In paragraph (c) of the definition of “relevant national Standard” the words “of the European Economic Community” shall be omitted.

(10) In the definition of “relevant notified body logo” for the word “logo”, wherever that word appears, there shall be substituted the words “identification number”.