The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019
| Jurisdiction | UK Non-devolved |
| Citation | SI 2019/791 |
(1) These Regulations may be cited as the Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 and, subject to F29paragraph (2) , come into force on exit day.regulation 4(4) ;regulation 5(3) ;regulation 6(3) ;regulation 8(2) ;regulation 9(2) .(2A) These regulations apply in relation to England and Wales and Scotland.(3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .In these Regulations— (1) Part 1 of the 2002 Regulations is amended as follows.(2) After regulation 1 (citation and commencement) insert—“ Subject to Parts VIII and IX, ” ;after the definition of “active implantable medical device” insert—“ as it had effect immediately before F38IP completion day” ;at the end of the definition of “Directive 93/42” insert “ as it had effect immediately before F39IP completion day” ;at the end of the definition of “Directive 98/79” insert “ as it had effect immediately before F40IP completion day” ;omit the definition of “Directive 2001/83”;omit the definition of “Directive 2006/42”;in the definition of “EC CAB” omit “EC”;omit the definition of “European Economic Area”;omit the definition of “harmonised standard”;in the definition of “intended for clinical investigation”, in paragraph (b) , for “a Member State” substitute “F42Great Britain” ;in the definition of “machinery” for “Article 2(a) of Directive 2006/42” substitute “ regulation 4 of the Supply of Machinery (Safety) Regulations 2008 ; ”;in the definition of “medicinal product” for “article 1.2 of Directive 2001/83” substitute “ regulation 2(1) of the Human Medicines Regulations 2012 ”;for the definition of “Mutual Recognition Agreements” substitute—“ F44Great Britain” ;at the end insert, “ and related expressions must be construed accordingly ” ;in the definition of “putting into service” in paragraph (b) F45for “the Community” substitute “Great Britain”;in the definition of “stable derivatives device”, in sub-paragraph (a) , for “article 1.10 of Directive 2001/83” substitute “ regulation 2(2) of the Human Medicines Regulations 2012 ” ;for the definition of “third country conformity assessment body” substitute—“ as they applied immediately before F49IP completion day and as modified by Schedule 2A. ” .(4A) After regulation 2 (interpretation) insert—“ the Human Medicines Regulations 2012 ” ;omit “governed by Title X of Directive 2001/83”;in paragraph (f) , for “Council Directive 76/768, as amended” substitute “ Regulation (EC) 1223/2009 of the European Parliament and of the Council of 30th November 2009 on cosmetic products; ” .(6) After regulation 3 insert—
- “approved body” is to be construed in accordance with regulation A45;
- “designated standard” has the meaning given in regulation 3A;
- “mutual recognition agreement” means an agreement that—
- (a) is between the United Kingdom and a country listed in Schedule 2, and
- (b) covers matters including the conditions under which the United Kingdom and the that country will accept or recognise the results of conformity assessment procedures undertaken by the each other's designated bodies;
- “third country conformity assessment body” means a body established in a country which is listed in Schedule 2 and designated in accordance with a relevant mutual recognition agreement to carry out conformity assessment procedures for the purposes of these Regulations;
- “UK marking” has the meaning given in Article 2(22) of Regulation (EC) No 765/2008;
- “UK responsible person” means a person established in F48any part of the United Kingdom who acts on behalf of a manufacturer established outside the United Kingdom in relation to specified tasks with regard to the manufacturer's obligations under these regulations.
- (1) Notwithstanding the effect of regulations 19B, 19C, 30A, 44ZA and 44ZB and the expiry of the period during which those regulations apply by virtue of regulation 1ZA, any medical device—
- (a) which meets the requirements of these Regulations as they apply in Northern Ireland; and
- (b) which is a qualifying Northern Ireland good, may be placed on the Great Britain market as if it meets the requirements of these Regulations as they apply in Great Britain.
- (1) In Parts II, III and IV of these Regulations, a “designated standard” means—
-
(a) a technical specification which is—
(i) adopted by a recognised standardisation body, for repeated or continuous application with which compliance is not compulsory; and (ii) designated by the Secretary of State by publishing a reference to the standard and maintaining that publication in a manner the Secretary of State considers appropriate; or - (b) a monograph of the European Pharmacopoeia (in particular on surgical sutures and on the interaction between medicinal products and materials used in devices containing medicinal products) which has been published in the Official Journal of the European Union.
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