# The Active Implantable Medical Devices Regulations 1992, Paragraph 2: Purpose of clinical investigation


The purposes of the clinical investigation are:
(a) to verify that, under normal conditions of use, the performances of the device comply with those indicated in paragraph 2 of Schedule 2; and
(b) to determine any undesirable side effects, under normal conditions of use, and assess whether they are reasonably acceptable risks having regard to the intended performance of the device.

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Source: https://www.legislation.gov.uk/uksi/1992/3146/schedule/3/paragraph/2 (the official version)
Page: https://openlegislation.uk/active-implantable-medical-devices-regulations-1992/schedule-3/paragraph-2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.

