Paragraph 10

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 manufacturer whose quality system for manufacture and inspection is approved shall authorise the notified body to carry out the inspections, and shall supply it with all the appropriate information, which the notified body needs to ensure that the manufacturer duly fulfils his obligations arising from the approved quality system, and that information shall include—

(a)

the documentation relating to the quality system;

(b)

the data stipulated in the part of the quality system relating to design, such as the results of analyses, calculations, tests, etc.;

(c)

the data stipulated in the part of the quality system relating to manufacture, such as reports concerning inspections, tests, standardisations, calibrations, the qualifications of the staff concerned, etc.

(2)

The notified body shall periodically carry out appropriate evaluations, including inspections, in order to ascertain that the manufacturer is applying the approved quality system, and shall supply the manufacturer with a report about any such evaluation.

(3)

In addition, the notified body may make inspections on unannounced visits to the manufacturer, and shall supply him with a report about any such inspection.

(4)

Every notified body shall communicate to the other notified bodies the information necessary to establish in respect of which quality systems it has issued, refused or withdrawn approval.