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Paragraph 2

Changes not yet applied. Later legislation changes this provision in ways not yet written into the text below:

(1)

The manufacturer shall undertake to the notified body to institute and keep up-dated a system of post-marketing surveillance.

(2)

The undertaking shall include an obligation for the manufacturer to notify the Secretary of State of the following events 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 his state of health;

(b)

any technical or medical reason resulting in withdrawal of a device from the market by the manufacturer.