Part I 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)