Paragraph 3

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

Sch.7, para.1 amended by Active Implantable Medical Devices (Amendment and Transitional Provisions) 1995 reg.17(2)
Sch.7, para.1A added by Active Implantable Medical Devices (Amendment and Transitional Provisions) 1995 reg.17(3)
Sch. 7, para.2(2)(a) amended by Active Implantable Medical Devices (Amendment and Transitional Provisions) 1995 reg.17(4)
Sch.7, para.3(1) substituted by Active Implantable Medical Devices (Amendment and Transitional Provisions) 1995 reg.17(5)
Sch.7, para.4(1) substituted by Active Implantable Medical Devices (Amendment and Transitional Provisions) 1995 reg.17(6)
Sch.7, para.4(4)(b) amended by Active Implantable Medical Devices (Amendment and Transitional Provisions) 1995 reg.17(7)
Sch.7, para.4(5) amended by Active Implantable Medical Devices (Amendment and Transitional Provisions) 1995 reg.17(8)
Sch.7, para.4(6A) added by Active Implantable Medical Devices (Amendment and Transitional Provisions) 1995 reg.17(9)
Sch.7, para.4(7) amended by Active Implantable Medical Devices (Amendment and Transitional Provisions) 1995 reg.17(10)
Sch.7, para.4(8) added by Active Implantable Medical Devices (Amendment and Transitional Provisions) 1995 reg.17(11)

(1)

The notified body shall carry out EC verification by controls and tests on the products on a statistical basis in accordance with paragraph 4.

(2)

The manufacturer shall authorise the notified body to evaluate the efficiency of the measures taken pursuant to paragraph 1, by audit where appropriate.