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Paragraph 1 Basis of clinical data

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

(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.