Regulation 11 Procedure for systems and procedure packs, and devices to be sterilised before use

(1)

Any person who puts together devices bearing the CE marking within their intended purpose and within the limits of use specified by their manufacturers in order to place them on the market as a system or procedure pack shall draw up a declaration that—

(a)

he has verified the mutual compatibility of the devices in accordance with the manufacturers' instructions and he has carried out his operations in accordance with these instructions;

(b)

he has packaged the system or procedure pack and supplied relevant information to users incorporating relevant instructions from the manufacturers; and

(c)

his operations are subjected to appropriate methods of internal control and inspection.

(2)

A system or procedure pack shall be treated as a device in its own right and shall be subjected to the relevant procedure under regulation 7, 8, 9 or 10 where—

(a)

it incorporates any device which does not bear a CE marking; or

(b)

the chosen combination of devices is intended to be put to a different use from any intended by the manufacturer of each device.

(3)

Any person who, for the purposes of placing on the market a system or procedure pack referred to in paragraph (2) or a CE marked medical device designed by its manufacturer to be sterilised before use, shall—

(a)

for the purposes of validating a sterilisation procedure, follow one of the procedures referred to in Annex IV, Annex V or Annex VI as it relates to the obtaining of sterility; and

(b)

make a written declaration that sterilisation has been carried out in accordance with the manufacturer’s instructions.

(4)

A conformity assessment procedure carried out by a notified body in relation to a system or procedure pack or device referred to in paragraph (3) shall be limited to the procedures referred to in paragraph (3)(a).

(5)

A system or procedure pack solely made up of devices bearing the CE marking—

(a)

shall not bear an additional CE marking; and

(b)

shall be accompanied by the information referred to in Section 13 of Annex I which shall include, where appropriate, the information supplied by the manufacturers of the devices which have been put together.

(6)

The declaration referred to in paragraphs (1) and (3)(b) shall be kept available for the Secretary of State for a period of five years.