Appendix 1
S.I. 2012/1426: memorandum from the Department
of Health
Medical Devices (Amendment) Regulations 2012
(S.I. 2012/1426)
1. In its letter to the Department of 27 June 2012,
the Joint Committee requested a memorandum on the following points:
Given the Committee's 27th Report for the 2010-12
Session (paragraph 2, relating to S.I. 2011/1456), explain -
(a) why regulation 3(3)(a) refers to "the
regulatory system established by the provision of these Regulations
....." rather than "the regulatory system established
by the provisions of the Medical Devices Regulations 2002 (as
amended by these Regulations)" that implement the Directives
mentioned in regulation 3(2), and
(b) why section 3 of the Explanatory Memorandum
indicates that there are no matters of special interest to the
Committee
2. The Department's response to each of the Committee's
points is set out below.
3. Point (a) - The Department accepts that in light
of the Committee's report relating to S.I. 2011/1456 regulation
3(3)(a) should have referred to "the regulatory system established
by the provisions of the Medical Devices Regulations 2002 (as
amended by these Regulations)". The Department apologises
for this error and will take steps to ensure that all drafters
and checkers are specifically made aware of the point. The Department
will make an appropriate amendment at the earliest practicable
opportunity.
4. Point (b) - In light of the Department's response
on (a) it follows that there were no matters of special interest
to be drawn to the attention of the Committee in relation to regulation
3(3)(a) in section 3 of the Explanatory Memorandum.
Department of Health
3 July 2012
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