# The Active Implantable Medical Devices Regulations 1992, Paragraph 1: Basis of clinical data


(1) Adequacy of the clinical data presented as part of the particulars referred to in paragraph 6(2) of Schedule 5 or included in the documentation mentioned in paragraphs 1(c) and 2 of Schedule 6 shall be based, account being taken as appropriate of relevant harmonised Standards, on either:
(a) a collation of currently available, relevant scientific literature covering the intended use of the device and the techniques for it as well as, if appropriate, a written report making a critical assessment of that collation; or
(b) the results of all clinical investigations made, and, in particular, the results of those carried out in accordance with paragraphs 2, 3 and 4.
(2) All the data presented must remain confidential unless it is essential that they be divulged.

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Source: https://www.legislation.gov.uk/uksi/1992/3146/schedule/3/paragraph/1 (the official version)
Page: https://openlegislation.uk/active-implantable-medical-devices-regulations-1992/schedule-3/paragraph-1
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.