Paragraph 4 Approval

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)

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.