Paragraph 4 Approval and 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)

(1)

The notified body shall effect an evaluation of the quality system to determine whether it fulfils the conditions specified in paragraph 3(2) to (4), and in doing so shall presume fulfilment of those conditions for a quality system which is in accordance with relevant harmonized Standards.

(2)

The team of individuals entrusted with the evaluation shall include at least one person who has already had experience of evaluations of the technology concerned.

(3)

The evaluation shall include an inspection at the manufacturer’s premises.

(4)

A decision as to whether or not approval is given shall be notified to the manufacturer after the final inspection and shall contain a reasoned evaluation and the conclusions of the notified body.