Amendment of regulation 2 in relation to England, Scotland and Wales (interpretation)
This section has no associated Explanatory Memorandum
4. In regulation 2(1)(1), insert at the appropriate place—
““statistical review” means a review of the statistical sections of the written notice which a manufacturer or their UK responsible person submits to the Secretary of State pursuant to regulation 16(1) or 29(1) in respect of an intended clinical investigation of a relevant device;”.
(1)
Amended by S.I. 2003/1697, 2007/400, 2008/2936, 2012/1426, 2013/2327, 2019/791, 2021/873, 2021/910 and section 41(4) of the Medicines and Medical Devices Act 2021 (c. 3).