Paragraph 2 Application for 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 application shall include—

(a)

a description of the type of devices manufacture of which is envisaged;

(b)

details of any relevant national Standard or harmonised Standard with which the devices comply;

(c)

the quality system documentation;

(d)

an undertaking by the manufacturer to fulfil the obligations arising from the quality system as approved;

(e)

an undertaking by the manufacturer to maintain the approved quality system in such a way that it remains adequate and efficacious;

(f)

an undertaking by the manufacturer to institute and keep up-dated a post-marketing surveillance system.

(2)

The undertaking referred to in sub-paragraph (1)(f) shall include an obligation for the manufacturer to notify the Secretary of State of the following incidents immediately on learning of them—

(a)

any deterioration in the characteristics or performances of, and any inaccuracies in the instruction leaflet for, a device which might lead to or have led to the death of a patient or a deterioration in the state of his health;

(b)

any technical or medical reason for withdrawal of a device from the market which results in such withdrawal by the manufacturer.