The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

JurisdictionUK Non-devolved
CitationSI 2019/791

2019 No. 791

Exiting The European UnionConsumer Protection

The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

Made 1st April 2019

Coming into force in accordance with regulation 1

The Secretary of State makes the following Regulations in exercise of the powers conferred by section 8(1) of, paragraph 7(2) of Schedule 4 and paragraph 21 of Schedule 7 to, the European Union (Withdrawal) Act 20181.

In accordance with paragraph 1(1) of Schedule 7 to the European Union (Withdrawal) Act 2018 a draft of this instrument has been laid before Parliament and approved by a resolution of each House of Parliament.

The Treasury has consented to the making of these Regulations as required by paragraph 10 of Schedule 4 to the European Union (Withdrawal) Act 2018.

S-1 Citation and commencement

Citation and commencement

1.—(1) These Regulations may be cited as the Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 and, subject to paragraphs (2) to (4), come into force on exit day.

(2) The following regulations come into force on the day that is 4 months after exit day—

(a)

(a) regulation 4(4);

(b)

(b) regulation 5(3);

(c)

(c) regulation 6(3);

(d)

(d) regulation 8(2);

(e)

(e) regulation 9(2).

(3) Regulation 10, insofar as it inserts regulations 91 to 95, comes into force on 26th May 2020.

(4) Regulation 11, insofar as it inserts regulation 157 to 160, comes into force on 26th May 2022.

S-2 Interpretation

Interpretation

2. In these Regulations—

“the Act” means the European Union (Withdrawal) Act 2018;

“the 2002 Regulations” means the Medical Devices Regulations 20022.

1 Amendment of the 2002 Regulations

PART 1

Amendment of the 2002 Regulations

S-3 Amendment of Part 1 of the 2002 Regulations

Amendment of Part 1 of the 2002 Regulations

3.—(1) Part 1 of the 2002 Regulations is amended as follows.

(2) After regulation 1(citation and commencement) insert—

S-1A

Schedules

1A. Schedules 2 to 28 have effect.”;

(3) In regulation 23(interpretation)—

(a)

(a) at the start, before “In these Regulations” insert “Subject to Parts VIII and IX,”;

(b)

(b) omit the definition of “Association Agreement”;

(c)

(c) in the definition of “authorised representative” —

(i) for “established within the Community” substitute “established outside the United Kingdom but within the European Economic Area”,

(ii) for “authorities and bodies in the Community” substitute “authorities and bodies in the European Economic Area”;

(d)

(d) after the definition of “clinical data” insert—

““designated standard” has the meaning given in regulation 3A;”;

(e)

(e) at the end of the definition of “Directive 90/385” insert “as it had effect immediately before exit day”;

(f)

(f) at the end of the definition of “Directive 93/42” insert “as it had effect immediately before exit day”;

(g)

(g) at the end of the definition of “Directive 98/79” insert “as it had effect immediately before exit day”;

(h)

(h) omit the definition of “Directive 2001/83”;

(i)

(i) omit the definition of “Directive 2006/42”;

(j)

(j) in the definition of “EC CAB” omit “EC”;

(k)

(k) omit the definition of “harmonised standard”;

(l)

(l) in the definition of “intended for clinical investigation”, in paragraph (b), for “a Member State” substitute “the United Kingdom”;

(m)

(m) in the definition of “machinery” for “Article 2(a) of Directive 2006/42” substitute “regulation 4 of the Supply of Machinery (Safety) Regulations 20084;”;

(n)

(n) in the definition of “medicinal product” for “article 1.2 of Directive 2001/83” substitute “regulation 2(1) of the Human Medicines Regulations 20125”;

(o)

(o) for the definition of “Mutual Recognition Agreements” substitute—

““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;”;

(p)

(p) omit the definition of “national standard”;

(q)

(q) in the definition of “notified body”

(i) omit “Part V or”;

(ii) for “the Mutual Recognition Agreements” substitute “a mutual recognition agreement”;

(iii) at the end insert “but, unless the context requires otherwise, does not include a UK notified body”;

(r)

(r) in the definition of “placing on the market”—

(i) for “Community” substitute “United Kingdom”;

(ii) at the end insert, “and related expressions must be construed accordingly”;

(s)

(s) in the definition of “putting into service” in paragraph (b) for “Community” substitute “United Kingdom”;

(t)

(t) 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”;

(u)

(u) for the definition of “third country conformity assessment body” substitute—

““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;”

(v)

(v) in the definition of “UK notified body” for “regulation 45” substitute “regulations 4F(8) and 4G(8)”;

(w)

(w) after the definition of “UK notified body” insert—

““UK responsible person” means a person established in 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.”

(4) In paragraph (1A), for the words “as amended from time to time” substitute “as they applied immediately before exit day and as modified by Schedule 2A.”.

(5) In regulation 36(scope of these Regulations)—

(a)

(a) for the heading substitute, “Scope of Parts II to VII”;

(b)

(b) in the opening words before paragraph (a), substitute “Parts II to VII of these Regulations do not apply to”;

(c)

(c) in paragraph (a)—

(i) for “Directive 2001/83” in the first place it occurs, substitute “the Human Medicines Regulations 2012”;

(ii) omit “governed by Title X of Directive 2001/83”;

(d)

(d) in paragraph (f), for “Council Directive 76/768, as amended” substitute “Regulation (EC) 1223/2009of the European Parliament and of the Council of 30th November 2009 on cosmetic products;”.

(6) After regulation 3 insert—

S-3A

Designated standard

3A.—(1) In Parts II, III, IV, VIII and IX of these Regulations a “designated standard” means a technical specification which is—

(a)

(a) adopted by a recognised standardisation body, for repeated or continuous application, with which compliance is not compulsory; and

(b)

(b) 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.

(2) For the purposes of paragraph (1), a “technical specification” means a document which prescribes technical requirements to be fulfilled by a device, process, service or system (“the product”) and which lays down—

(a)

(a) the characteristics required of a product, including levels of quality, performance, interoperability, environmental protection, health and safety and dimensions;

(b)

(b) the requirements applicable to the product as regards the name under which the product is sold, terminology, symbols, testing and test methods, packaging, marking or labelling and conformity assessment procedures; and

(c)

(c) the production methods and processes relating to the product, where these have an effect on its characteristics.

(3) For the purposes of this regulation a “recognised standardisation body” means any one of the following organisations—

(a)

(a) the European Committee for Standardisation (CEN);

(b)

(b) the European Committee for Electrotechnical Standardisation (CENLAC);

(c)

(c) the British Standards Institute (BSI).

(4) When considering whether the manner of publication of a reference is appropriate in accordance with paragraph (1)(b), the Secretary of State must have regard to whether the publication will draw the standard to the attention of any person who may have an interest in the standard.

(5) Before publishing the reference to a standard in relation to a technical specification which has been adopted by BSI, the Secretary of State must have regard to whether the technical specification is consistent with technical specifications adopted by the other recognised standardisation bodies.

(6) The Secretary of State may remove from publication the reference to a standard which has been published in accordance with paragraph (1)(b).

(7) Where the Secretary of State removes the reference to a standard from publication, that standard is no longer a designated standard.

(8) In this regulation, a reference to a “device” is a reference to a medical device or its accessory or an in vitro diagnostic medical device or its accessory to which these Regulations apply.

S-3B

Confidentiality

3B.—(1) Subject to paragraph (2), and unless otherwise provided for in these Regulations, all parties involved in the application of these Regulations must respect the confidentiality of information and data obtained in carrying out their tasks in order to protect the following—

(a)

(a) personal data in accordance with the Data Protection Act 20187;

(b)

(b) commercially confidential information, trade secrets of a person, including intellectual property rights (unless disclosure is in the public interest);

(c)

(c) the effective operation of these Regulations, in particular for the purposes of inspections, investigations or audits.

(2) Paragraph (1) does not affect—

(a)

(a) the rights and obligations of the Secretary of State, manufacturers, persons placing products on the market, UK responsible persons, importers, distributors and notified bodies (including UK notified bodies) with regard to the exchange of information and the dissemination of warnings;

(b)

(b) obligations to...

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