Paragraph 1 Making and consideration of application

Changes not yet applied. Later legislation changes this provision in ways not yet written into the text below:

Sch.6, para.7 substituted by Active Implantable Medical Devices (Amendment and Transitional Provisions) 1995 reg.16(2)
Sch.6, para.8(2) amended by Active Implantable Medical Devices (Amendment and Transitional Provisions) 1995 reg.16(3)
Sch.6, paras.9,10 added by Active Implantable Medical Devices (Amendment and Transitional Provisions) 1995 reg.16(4)

(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.