Paragraph 5 Modifications

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)

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.