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

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Amendment of regulation 4 of the principal Regulations

5.—(1) Regulation 4 of the principal Regulations (EC mark) shall be amended in accordance with the following provisions of this regulation.

(2) In paragraph (1) for the words “accompanied by the relevant notified body logo” there shall be substituted the words “followed by the relevant notified body identification number”.

(3) In sub-paragraph (b) of paragraph (1) there shall be inserted at the beginning the words “where appropriate,”.

(4) In paragraph (3) for the words “a mark which is likely to be confused with the EC mark” there shall be substituted the words “a marking which is likely to deceive third parties as to the meaning and form of the CE marking”.

(5) After paragraph (3) there shall be added the following paragraphs—

“(4) Any other marking may be affixed to a device’s packaging or to the instruction leaflet accompanying the device, provided that the visibility and legibility of the CE marking are not thereby reduced.

(5) Where a device comes within the scope of a directive other than the Directive and that other directive provides for the affixing of the CE marking, the CE marking shall not be affixed unless the relevant requirements of that other directive are also satisfied.

(6) Where a directive other than the Directive permits a manufacturer to choose which arrangements to apply during a transitional period, the CE marking shall indicate that the device fulfils only the provisions of those directives applied by the manufacturer.

(7) In a case falling within paragraph (6), particulars of the directives applied by the manufacturer, as published in the Official Journal of the European Communities, shall be given in the documents, notices or instructions required by the directives and accompanying the device, and these documents, notices or instructions shall be accessible without it being necessary to destroy the packaging which keeps the device sterile.”.

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