Regulation 5(3)
SCHEDULE 6EC TYPE-EXAMINATION PROCEDURE (CORRESPONDING TO ANNEX 3 OF THE DIRECTIVE)
Making and consideration of application
1.—(1) An application for EC type-examination shall be made in writing by the manufacturer, or by his authorised representative, to a notified body.
(2) The application shall include—
(a)the name and address of the manufacturer and the name and address of the authorised representative if the application is made by the latter;
(b)a written declaration that an application has not been made to any other notified body;
(c)the documentation specified in paragraph 2 needed to allow an evaluation to be made of the conformity of a representative sample of the production in question (hereinafter referred to as “type”), with the requirements of the Directive.
(3) The applicant shall make available to the notified body a type and such other samples as the notified body may request.
2. The documentation referred to in paragraph 1(2)(c) is that which makes it possible to understand the design, the manufacture and the performances of the device, containing in particular the following items:
(a)a general description of the device;
(b)design drawings, a description of the methods of manufacture envisaged, in particular as regards sterilisation, and diagrams of parts, sub-assemblies, circuits and other compo nents and accessories;
(c)the descriptions and explanations necessary for the understanding of those drawings and diagrams and of the operation of the device;
(d)a list of the relevant national Standards applied in full or in part, and a description of the solutions adopted to satisfy the relevant essential requirements where the relevant national Standards have not been applied;
(e)the results of design calculations, investigations and technical tests carried out and other design verification data;
(f)a statement as to whether or not the device incorporates, as an integral part, a substance described in paragraph 10 of Schedule 2 whose action in combination with the device may result in its bioavailability, together with data on the relevant trials conducted;
(g)clinical data in accordance with paragraph 1 of Schedule 3;
(h)the draft instruction leaflet.
3. The notified body shall—
(a)examine and evaluate the documentation;
(b)verify that the type has been manufactured in accordance with that documentation;
(c)record the items which have been designed in accordance with the applicable provisions of the relevant national Standards, and the items which have not been so designed;
(d)where the relevant national Standards have not been applied, carry out or have carried out the inspections and the tests necessary to verify whether the solutions adopted by the manufacturer satisfy the relevant essential requirements;
(e)where the manufacturer has chosen to apply the relevant national Standards, carry out or have carried out the inspections and the tests necessary to verify whether they have actually been applied;
(f)seek agreement with the applicant on the place where the necessary inspections and tests will be carried out.
Approval
4.—(1) Where the type complies with the provisions of the Directive, the notified body shall signify approval by issuing an EC type-examination certificate to the applicant.
(2) A certificate relating to a type shall contain the name and address of the manufacturer, the conclusions of the evaluation of the type, the conditions under which the certificate is valid and the information necessary for identification of the type.
(3) The notified body shall attach to the certificate what it considers to be the significant parts of the documentation and shall keep a copy of the certificate and of those parts of the documentation.
Modifications
5.—(1) The applicant shall inform the relevant notified body of any modification made to a device in relation to which an EC type-examination certificate has been issued.
(2) Any such modification must receive approval from the relevant notified body where it may affect conformity with the relevant essential requirements or with the conditions of use specified for the device.
(3) Any such approval shall be issued, where appropriate, in the form of a supplement to the initial EC type-examination certificate.
(4) In this paragraph and paragraph 6 “relevant notified body” in relation to a device means the notified body which issued the EC type-examination certificate in respect of it, except that where that body is no longer a notified body as respects tasks under this paragraph it means such other notified body as the Secretary of State shall have designated in relation to that device or devices of that type.
6. The relevant notified body—
(a)shall withdraw any EC type-examination certificate or supplementary approval given by it if it considers that the device no longer conforms with the relevant essential requirements or the conditions of use specified for the device; and
(b)may withdraw the EC type-examination certificate or supplementary approval if it has been given on the basis of false or misleading information.
Notifications, etc.
7. Each notified body shall communicate to the other notified bodies the information necessary to establish in respect of which devices it has issued, refused or withdrawn EC type-examination certificates and supplements.
8.—(1) A notified body shall, if so requested by another notified body, provide that other body with a copy of EC type-examination certificates, and of any supplements to them, which it has issued.
(2) A notified body shall make available to another notified body which so requests, giving reasons for its request, copies of those parts of the documentation which are attached to a certificate under paragraph 4(3), but shall not do so without having first informed the manufacturer.