(i) in sub-paragraph (1), for “30” substitute “30A”;

(ii) in sub-paragraph (2), for “30” substitute “30A”.

(3) The Medical Devices Regulations 2002 (S.I. 2002/618S.I. 2002/618) are amended in
accordance with subsections (4) to (7).

(4) 5In regulation 2 (interpretation), in paragraph (1) omit the definition of “the
1987 Act”.

(5) Omit regulation 3B (confidentiality).

(6) In regulation 61 (enforcement and the Consumer Protection Act 1987 etc), for
paragraphs (1) to (8) substitute—

“(1A) 10It is the duty of the Secretary of State to enforce these regulations in
relation to relevant devices and devices for performance evaluation.

(1B) It is the duty of each weights and measures authority in Great Britain
and each district council in Northern Ireland to enforce these
regulations within its area (concurrently with the Secretary of State) in
15relation to relevant devices that are ordinarily intended for private use
or consumption.

(1C) Nothing in this regulation authorises a weights and measures authority
to bring proceedings in Scotland for an offence.”

(7) Omit—

(a) 20regulation 62 (compliance notices),

(b) regulation 63 (restriction notices), and

(c) regulation 64 (notification of decisions etc).

(8) As a result of the amendments made by subsections (1), (4), (6) and (7), the
Medical Devices Regulations 2002 are not to be recognised as safety
25regulations for the purposes of the Consumer Protection Act 1987, but those
amendments do not otherwise affect the continued operation of those
regulations.

(9) Schedule 2 makes it an offence to breach various provisions in the Medical
Devices Regulations 2002.

CHAPTER 4 30Interpretation of Part 3

37 Interpretation of Part 3

(1) In this Part, apart from in sections 27, 28 and 29 (provisions relating to
forfeiture or seizure of medical devices), references to a medical device include
references to a type of medical device.

(2) 35In this Part—

• the “appropriate appeals court” means—

  (a)

  in England and Wales, the Crown Court;

  (b)

  in Scotland, the Sheriff Appeal Court;

  (c)

  in Northern Ireland, a county court;

• 40the “appropriate lower court” means—

  Medicines and Medical Devices BillPage 21

  (a)

  in England and Wales, a magistrates’ court;

  (b)

  in Scotland, the sheriff;

  (c)

  in Northern Ireland, a court of summary jurisdiction;

• “compliance notice” has the meaning given by section 16(2);

• 5“data protection legislation” has the meaning given by section 3(9) of the
  Data Protection Act 2018;

• the “enforcement authority” means—

  (a)

  in relation to medical devices which are ordinarily intended for
  private use or consumption—

  (i)

  10a local weights and measures authority in Great Britain
  or a district council in Northern Ireland, or

  (ii)

  the Secretary of State, or

  (b)

  in relation to other medical devices, the Secretary of State;

• “EU Medical Devices Regulations” means—

  (a)

  15Regulation (EU) 2017/745 of the European Parliament and of
  the Council of 5 April 2017 on medical devices, amending
  Directive 2001/83/EC, Regulation (EC) No 178/2002 and
  Regulation (EC) No 1223/2009 and repealing Council
  Directives 90/385/EEC and 93/42/EEC, and

  (b)

  20Regulation (EU) 2017/746 of the European Parliament and of
  the Council of 5 April 2017 on in vitro diagnostic medical
  devices and repealing Directive 98/79/EC and Commission
  Decision 2010/227/EU;

• “forfeiture order” has the meaning given by section 27(1);

• 25“information notice” has the meaning given by section 19(2);

• “manufacture” includes assembly;

• “manufacturer” means any person who is a manufacturer for the
  purposes of any provision in the Medical Devices Regulations 2002 (S.I.
  2002/618);

• 30“medical device” includes—

  (a)

  medical devices to which the Medical Devices Regulations 2002
  apply, and

  (b)

  devices to which the EU Medical Devices Regulations apply;

• “medical devices provision” has the meaning given by section 14(2);

• 35“relevant requirements” has the meaning given by section 13(1)(a);

• “safety notice” has the meaning given by section 18(1);

• “suspension notice” has the meaning given by section 17(2).

Part 4 Regulations under Parts 1, 2 and 3

38 40Power to make consequential etc provision

Regulations under sections 1(1), 8(1) and 12(1) may—

(a) make consequential, supplementary, incidental, transitional, transitory
or saving provision;

(b) make different provision for different purposes;

(c) 45make different provision for different areas;

(d) make provision for all cases to which the power applies or for those
cases subject to specified exceptions or for any specified cases or
descriptions of case.

39 Scope of powers of Northern Ireland departments

5No provision may be made by a Northern Ireland department acting alone in
regulations under section 1(1) or 8(1) unless the provision, if it were contained
in an Act of the Northern Ireland Assembly—

(a) would be within the legislative competence of the Assembly, and

(b) would not require the consent of the Secretary of State.

40 10Consultation

(1) Before making regulations under sections 1(1), 8(1) or 12(1), or paragraph 9 of
Schedule 1, the relevant authority must consult such persons as the authority
considers appropriate.

(2) The duty to consult imposed by subsection (1) does not apply in relation to
15regulations that contain only provision made in reliance on—

(a) section 6 (disapplication of provisions relating to human medicines
where there is a risk of serious harm to health), or

(b) section 15 (disapplication of provisions relating to medical devices
where there is a risk of serious harm to health),

20where the regulations contain a declaration that the person making them
considers that they need to be made urgently to protect the public from an
imminent risk of serious harm to health.

(3) The duty to consult imposed by subsection (1) may be satisfied by consultation
carried out before this Act was passed.

(4) 25In this section, “the relevant authority” means—

(a) in relation to regulations made under section 1(1) or 8(1), the
appropriate authority within the meaning given by section 1(4) or 8(4)
as the case may be, and

(b) in relation to regulations made under section 12(1) or paragraph 9 of
30Schedule 1, the Secretary of State.

41 Procedure

(1) Any power to make regulations under section 1(1), 8(1) or 12(1), or paragraph
9 of Schedule 1, so far as exercisable by the Secretary of State, or by the
Secretary of State acting jointly with a Northern Ireland department, is
35exercisable by statutory instrument.

(2) Any power to make regulations under section 1(1) or 8(1) so far as exercisable
by a Northern Ireland department (other than when acting jointly with the
Secretary of State) is exercisable by statutory rule for the purposes of the
Statutory Rules (Northern Ireland) Order 1979 (S.I. 1979/1573 (N.I. 12)S.I. 1979/1573 (N.I. 12)) (and
40not by statutory instrument).

(3) Subject to subsection (6), a statutory instrument containing regulations of the
Secretary of State acting alone under section 1(1), 8(1) or 12(1) may not be made
unless a draft of the instrument has been laid before and approved by a
resolution of each House of Parliament.

(4) Subject to subsection (7), regulations of a Northern Ireland department acting
alone under section 1(1) or 8(1) may not be made unless a draft of the
regulations has been laid before and approved by a resolution of the Northern
Ireland Assembly.

(5) 5Subject to subsection (8), a statutory instrument containing regulations of the
Secretary of State and a Northern Ireland department acting jointly under
section 1(1) or 8(1) may not be made unless a draft of the instrument has been
laid before and approved by a resolution of—

(a) each House of Parliament, and

(b) 10the Northern Ireland Assembly.

(6) A statutory instrument containing regulations of the Secretary of State acting
alone to which subsection (9) applies is subject to annulment in pursuance of a
resolution of either House of Parliament.

(7) Regulations of a Northern Ireland department acting alone to which
15subsection (9) applies are subject to negative resolution within the meaning
given by section 41(6) of the Interpretation Act (Northern Ireland) 1954.

(8) A statutory instrument containing regulations of the Secretary of State and a
Northern Ireland department acting jointly to which subsection (9) applies is
subject to—

(a) 20annulment in pursuance of a resolution of either House of Parliament,
and

(b) negative resolution within the meaning given by section 41(6) of the
Interpretation Act (Northern Ireland) 1954.

(9) This subsection applies to regulations that contain only provision made in
25reliance on—

(a) section 2(1)(j), (k) or (n),

(b) section 5(1)(a),

(c) section 6, where the regulations contain a declaration that the person
making them considers that they need to be made urgently to protect
30the public from an imminent risk of serious harm to health,

(d) section 9(1)(f), (k) or (l),

(e) section 10(1)(a),

(f) section 14(1)(a), or

(g) section 15, where the regulations contain a declaration that the
35Secretary of State considers that they need to be made urgently to
protect the public from an imminent risk of serious harm to health.

(10) A statutory instrument containing regulations under paragraph 9 of Schedule
1 is subject to annulment in pursuance of a resolution of either House of
Parliament.

40Part 5 Extent, commencement and short title

42 Extent

This Act extends to England and Wales, Scotland and Northern Ireland.

43 Commencement

(1) The following come into force on the day on which this Act is passed—

(a) this Part,

(b) section 1,

(c) 5section 6,

(d) section 7,

(e) section 12,

(f) section 15,

(g) section 37, and

(h) 10Part 4.

(2) The following come into force at the end of the period of two months beginning
with the day on which this Act is passed—

(a) the remaining provisions of Part 1,

(b) Part 2, and

(c) 15the remaining provisions of Chapter 1 of Part 3.

(3) Chapters 2 and 3 of Part 3 (medical devices: enforcement and disclosure of
information) come into force on such day or days as the Secretary of State may
by regulations made by statutory instrument appoint.

(4) Regulations may not be made in reliance on section 6 or 15 that come into force
20before the end of the period of two months beginning with the day on which
this Act is passed unless they contain a declaration that the person making
them considers that they need to be made urgently to protect the public from
an imminent risk of serious harm to health.

44 Transitional etc provision in connection with commencement

(1) 25The Secretary of State may by regulations made by statutory instrument make
transitional, transitory or saving provision in connection with the coming into
force of any provision of this Act (subject to subsection (4)).

(2) The relevant Northern Ireland department may by regulations make
transitional, transitory or saving provision in connection with the coming into
30force of Part 1 or, as the case may be, Part 2 so far as relating to Northern
Ireland.

(3) No provision may be made by the relevant Northern Ireland department in
regulations under subsection (2) unless the provision, if it were contained in an
Act of the Northern Ireland Assembly—

(a) 35would be within the legislative competence of the Assembly, and

(b) would not require the consent of the Secretary of State.

(4) Regulations of the Secretary of State under this section may not contain
provision that could be made by regulations of the relevant Northern Ireland
department under this section.

(5) 40The power to make regulations under subsection (2) is exercisable by statutory
rule for the purposes of the Statutory Rules (Northern Ireland) Order 1979 (S.I.
1979/1573 (N.I. 12)).

(6) In this section, the “relevant Northern Ireland department” means—

(a) in relation to Part 1, the Department of Health in Northern Ireland, and

(b) in relation to Part 2, the Department of Agriculture, Environment and
Rural Affairs in Northern Ireland.

45 Short title

This Act may be cited as the Medicines and Medical Devices Act 2020.

SCHEDULES

Section 26

SCHEDULE 1 Medical devices: civil sanctions

Part 1 5Monetary penalties

Imposition of monetary penalty

1 (1) The Secretary of State may impose a monetary penalty on a person if
satisfied beyond reasonable doubt that the person has committed an offence
under—

(a) 10section 23 (offence of breaching enforcement notice), or

(b) regulation 60A of the Medical Devices Regulations 2002 (S.I. 2002/
618) (offence of breaching certain provisions in the Regulations).

(2) In this Schedule “monetary penalty” means a requirement to pay to the
Secretary of State a penalty of an amount determined by the Secretary of
15State.

Notices, representations and appeals etc

2 (1) Where the Secretary of State proposes to impose a monetary penalty on a
person, the Secretary of State must serve on the person a notice of what is
proposed.

(2) 20A notice under sub-paragraph (1) must offer the person the opportunity to
avoid liability in relation to a monetary penalty by payment of a sum
specified in the notice (which must be less than or equal to the amount of the
penalty).

(3) The person may make written representations and objections to the
25Secretary of State in relation to the proposed imposition of the monetary
penalty.

(4) After the end of the period for making such representations and objections
(see paragraph 3(2)) the Secretary of State must decide whether to serve on
the person a notice imposing the monetary penalty.

(5) 30 The Secretary of State may not impose a monetary penalty on a person if the
Secretary of State is no longer satisfied as mentioned in paragraph 1(1).

(6) A person on whom a monetary penalty is imposed may appeal against the
decision to impose the penalty on the ground—

(a) that the decision was based on an error of fact,

(b) 35that the decision was wrong in law,

(c) that the amount of the penalty is unreasonable, or

(d) that the decision is unfair, unreasonable or wrong for any other
reason.

(7) An appeal under sub-paragraph (6) is to the First-tier Tribunal.

(8) 5Where an appeal is on the ground that the appellant did not commit an
offence as mentioned in paragraph 1(1), the Tribunal must allow the appeal
unless satisfied beyond reasonable doubt that the appellant committed the
offence in question, according to the same burden of proof as would apply
if the Secretary of State were seeking to prove the matter in a criminal
10prosecution.

Information to be included in notices under paragraph 2

3 (1) A notice under paragraph 2(1) must include information as to—

(a) the grounds for the proposal to impose the monetary penalty;

(b) the effect of payment of the sum referred to in paragraph 2(2);

(c) 15the right to make representations and objections;

(d) the circumstances in which the Secretary of State may not impose the
monetary penalty.

(2) A notice under paragraph 2(1) must also specify—

(a) the period within which payment may be made so as to avoid
20liability for a monetary penalty, and

(b) the period within which representations and objections may be
made.

Neither period may be more than 28 days beginning with the day on which
the notice is served.

(3) 25A notice under paragraph 2(4) imposing a monetary penalty must include
information as to—

(a) the grounds for imposing the monetary penalty;

(b) how payment may be made;

(c) the period within which payment is to be made;

(d) 30any early payment discounts or late payment penalties (including
interest on payments);

(e) rights of appeal;

(f) the consequences of non-payment.

The period referred to in paragraph (c) must be at least 28 days beginning
35with the day on which the notice is served.

Monetary penalties: criminal proceedings and conviction

4 (1) Where a notice under paragraph 2(1) is served on a person—

(a) no criminal proceedings for an offence under section 23 or regulation
60A of the Medical Devices Regulations 2002 may be instituted
40against the person in respect of the act or omission to which the
notice relates before the end of the period within which the person’s
liability may be discharged as mentioned in paragraph 2(2) (see
paragraph 3(2)(a));

(b) if the liability is so discharged, the person may not at any time be
45convicted of an offence under section 23 or regulation 60A of the
Medical Devices Regulations 2002 in relation to that act or omission.

(2) A person on whom a monetary penalty is imposed may not at any time be
convicted of an offence under section 23 or regulation 60A of the Medical
Devices Regulations 2002 in respect of the act or omission giving rise to the
penalty.

5Part 2 Enforcement undertakings

5 (1) This paragraph applies where—

(a) the Secretary of State has reasonable grounds to suspect that a person
has committed an offence under section 23 or regulation 60A of the
10Medical Devices Regulations 2002,

(b) the person offers an undertaking (an “enforcement undertaking”) to
take specified action within a specified period,

(c) the action specified is—

(i) action to secure that the offence does not continue or recur, or

(ii) 15action of a description set out in supplementary regulations
(see Part 4 of this Schedule), and

(d) the Secretary of State accepts the undertaking.

(2) Unless the person fails to comply with the undertaking or any part of it—

(a) the person may not at any time be convicted of an offence under
20section 23 or regulation 60A of the Medical Devices Regulations 2002
in respect of the act or omission to which the undertaking relates;

(b) the Secretary of State may not impose on the person any monetary
penalty that the Secretary of State would otherwise have power to
impose by virtue of paragraph 1 in respect of that act or omission.

25Part 3 Enforcement costs recovery notices

Imposition of enforcement costs recovery notices

6 (1) The Secretary of State may serve an enforcement costs recovery notice on a
person on whom a monetary penalty has been imposed.

(2) 30For the purposes of this Schedule an “enforcement costs recovery notice” is
a notice requiring the person to pay to the Secretary of State the costs
incurred by the Secretary of State in relation to the monetary penalty up to
the time when it was imposed.

(3) In sub-paragraph (2), “costs” includes (in particular)—

(a) 35investigations costs;

(b) administration costs;

(c) costs of obtaining expert advice (including legal advice).

Information to be included in enforcement costs recovery notices

7 (1) An enforcement costs recovery notice must specify the amount to be paid
40and must include information as to—

(a) the grounds for serving the notice;

(b) how payment may be made;

(c) the period within which payment is to be made;

(d) any early payment discounts or late payment penalties;

(e) rights to make written representations and objections in relation to
the enforcement costs recovery notice;

(f) 5rights of appeal;

(g) the consequences of non-payment.

The period referred to in paragraph (c) must be at least 28 days beginning
with the day on which the enforcement costs recovery notice is served.

(2) A person required by an enforcement costs recovery notice to pay an
10amount to the Secretary of State may require the Secretary of State to provide
a detailed breakdown of that amount.

Appeals

8 (1) A person served with an enforcement costs recovery notice may appeal
against the decision to serve it on the ground—

(a) 15that the decision was based on an error of fact,

(b) that the decision was wrong in law,

(c) that the decision was unreasonable, or

(d) that any of the costs to which the notice relates were unreasonably
incurred or unreasonable in amount,

20or on any other grounds that are set out in supplementary regulations (see
Part 4 of this Schedule).

(2) An appeal under sub-paragraph (1) is to the First-tier Tribunal.

Part 4 Power to make supplementary provision etc by regulations

25Supplementary regulations: general

9 (1) The Secretary of State may by regulations (“supplementary regulations”)—

(a) make provision specified in paragraphs 10 to 12 supplementing that
made by this Schedule;

(b) make provision that is consequential on or incidental to that made by
30this Schedule;

(c) make transitional, transitory or saving provision in relation to earlier
supplementary regulations.

(2) Regulations made under sub-paragraph (1) may—

(a) make different provision for different purposes;

(b) 35make different provision for different areas;

(c) make provision for all cases to which the power applies or for those
cases subject to specified exceptions or for any specified cases or
descriptions of case.

Monetary penalties and costs

10 (1) 40Supplementary regulations may make provision of any of the following
sorts in relation to the power of the Secretary of State to impose a monetary
penalty under paragraph 1 or costs under paragraph 6—