# The Active Implantable Medical Devices Regulations 1992, Paragraph 2


(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.

---
Source: https://www.legislation.gov.uk/uksi/1992/3146/schedule/7/paragraph/2 (the official version)
Page: https://openlegislation.uk/active-implantable-medical-devices-regulations-1992/schedule-7/paragraph-2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.