Paragraph 3 Making and consideration of application

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)

The notified body shall—

(a)

examine and evaluate the documentation;

(b)

verify that the type has been manufactured in accordance with that documentation;

(c)

record the items which have been designed in accordance with the applicable provisions of the relevant national Standards, and the items which have not been so designed;

(d)

where the relevant national Standards have not been applied, carry out or have carried out the inspections and the tests necessary to verify whether the solutions adopted by the manufacturer satisfy the relevant essential requirements;

(e)

where the manufacturer has chosen to apply the relevant national Standards, carry out or have carried out the inspections and the tests necessary to verify whether they have actually been applied;

(f)

seek agreement with the applicant on the place where the necessary inspections and tests will be carried out.