Paragraph 8 Notifications, etc.

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)

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.