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

Amendment of Schedule 6 to the principal Regulations

16.—(1) Schedule 6 to the principal Regulations (EC type-examination procedure) shall be amended in accordance with the following provisions of this regulation.

(2) For paragraph 7 there shall be substituted the following paragraph—

“7.   Each notified body shall make available to the other notified bodies or to the Secretary of State, on their or her request, the information necessary to establish in respect of which devices it has issued, refused or withdrawn EC type-examination certificates and addenda.”.

(3) In sub-paragraph (2) of paragraph 8 for the words “copies of those parts of the documentation which are attached to a certificate under paragraph 4(3)” there shall be substituted the words “a copy of any annex to a certificate”.

(4) After paragraph 8 there shall be added the following paragraphs—

“9.   The manufacturer or his authorised representative shall keep with the technical documentation a copy of the EC type-examination certificates and the supplements to them for a period of at least five years from the date of manufacture of the last appliance.

10.   Where neither the manufacturer nor his authorised representative is established in the Community, the obligation to keep available the technical documentation for the Secretary of State shall fall upon the person responsible for placing the device on the market.”.