Paragraph 1 Application for evaluation of quality system

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

Sch.5, para.2(1) amended by Active Implantable Medical Devices (Amendment and Transitional Provisions) 1995 reg.15(2)
Sch.5, para.3(4)(b)(ii) amended by Active Implantable Medical Devices (Amendment and Transitional Provisions) 1995 reg.15(3)
Sch.5, para.10(4) substituted by Active Implantable Medical Devices (Amendment and Transitional Provisions) 1995 reg.15(4)
Sch.5, para.10(5)(6) added by Active Implantable Medical Devices (Amendment and Transitional Provisions) 1995 reg.15(5)

A manufacturer who wishes to have his quality system for design, manufacture and final inspection approved shall make an application in writing to a notified body for evaluation of his quality system.