Paragraph 9 Design examination certificate

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)

The relevant notified body—

(a)

shall withdraw any EC design examination certificate or supplementary approval given by it if it considers that the device no longer conforms with the relevant essential requirements or the conditions prescribed for the use of the type of device; and

(b)

may withdraw the EC design examination certificate or supplementary approval if it has been given on the basis of false or misleading information.