Medicines and Medical Devices Bill (HC Bill 90)

Medicines and Medical Devices BillPage 30

(a) provision for early payment discounts;

(b) provision for the payment of interest or other financial penalties for
late payment;

(c) provision for enforcement.

(2) 5Provision made by virtue of sub-paragraph (1)(b) must secure that the
interest or other financial penalties for late payment do not in total exceed
the amount of the penalty or costs to which the interest or other financial
penalties relate.

(3) Provision made by virtue of sub-paragraph (1)(c) may include—

(a) 10provision for the Secretary of State to recover the penalty or costs,
and any interest or other financial penalty for late payment, as a civil
debt;

(b) provision for the penalty or costs, and any interest or other financial
penalty for late payment, to be recoverable, on the order of a court,
15as if payable under a court order.

Enforcement undertakings

11 Supplementary regulations may make provision of any of the following
sorts in relation to an enforcement undertaking—

(a) provision as to the procedure for entering into an undertaking;

(b) 20provision as to the terms of an undertaking;

(c) provision as to publication of an undertaking by the Secretary of
State;

(d) provision as to variation of an undertaking;

(e) provision as to circumstances in which a person may be regarded as
25having complied with an undertaking;

(f) provision as to monitoring by the Secretary of State of compliance
with an undertaking;

(g) provision as to certification by the Secretary of State that an
undertaking has been complied with;

(h) 30provision for appeals against refusal to give such certification;

(i) in a case where a person has given inaccurate, misleading or
incomplete information in relation to an undertaking, provision for
the person to be regarded as not having complied with it;

(j) in a case where a person has complied partly but not fully with an
35undertaking, provision for that part-compliance to be taken into
account in the imposition of any criminal or other sanction on the
person.

Appeals

12 (1) Supplementary regulations may make provision of any of the following
40sorts in relation to an appeal in respect of the imposition of a requirement or
the service of a notice under this Schedule—

(a) provision suspending the requirement or notice pending
determination of the appeal (and providing for time during which
the requirement or notice is suspended not to be taken into account
45in calculating any period of time relating to the requirement or
notice);

Medicines and Medical Devices BillPage 31

(b) provision as to the powers of the tribunal to which the appeal is
made.

(2) Provision made by virtue of sub-paragraph (1)(b) may (among other things)
include provision conferring on the tribunal to which the appeal is made—

(a) 5power to withdraw the requirement or notice;

(b) power to confirm the requirement or notice;

(c) power to take any steps that the Secretary of State could take in
relation to the act or omission giving rise to the requirement or
notice;

(d) 10power to remit the decision whether to confirm the requirement or
notice, or any matter relating to that decision, to the Secretary of
State.

Part 5 General and supplemental

15Guidance as to enforcement

13 (1) The Secretary of State must prepare and publish guidance as to—

(a) the sanctions that may be imposed on a person who commits an
offence under section 23 or regulation 60A of the Medical Devices
Regulations 2002;

(b) 20the action that the Secretary of State may take in relation to such a
person;

(c) the circumstances in which the Secretary of State is likely to take any
such action.

(2) The guidance must include guidance about the Secretary of State’s use of the
25power to impose a monetary penalty, with information as to—

(a) the circumstances in which such a penalty may not be imposed;

(b) the amount of such a penalty;

(c) the matters likely to be taken into account by the Secretary of State in
determining that amount (including, where relevant, any discounts
30for voluntary reporting of non-compliance);

(d) how liability for such a penalty may be discharged and the effect of
discharge;

(e) rights to make representations and objections and rights of appeal in
relation to such a penalty.

(3) 35The guidance must include guidance about the Secretary of State’s use of the
power to serve an enforcement costs recovery notice, with information as
to—

(a) the circumstances in which such a notice may not be served;

(b) the amount that a person may be required to pay;

(c) 40the matters likely to be taken into account by the Secretary of State in
determining that amount;

(d) how liability for the costs to which the notice relates may be
discharged and the effect of discharge;

(e) rights to make representations and objections and rights of appeal in
45relation to those costs.

Medicines and Medical Devices BillPage 32

(4) The guidance must include guidance about the Secretary of State’s use of the
power to accept an enforcement undertaking.

(5) Where appropriate, the Secretary of State must revise guidance published
under this paragraph and publish the revised guidance.

(6) 5Before publishing guidance or revised guidance under this paragraph, the
Secretary of State must consult—

(a) the Welsh Ministers, the Scottish Ministers and the Department of
Health in Northern Ireland, and

(b) any other persons the Secretary of State considers appropriate.

(7) 10The Secretary of State must have regard to the guidance or revised guidance
published under this paragraph in exercising functions under this Schedule.

Pre-commencement consultation

14 If, before the day on which this Schedule comes into force, any consultation
was undertaken which, had it been undertaken after that day, would to any
15extent have satisfied the requirements of section 40 or paragraph 13, those
requirements are to that extent to be taken to have been satisfied.

Reports on use of civil sanctions

15 (1) The Secretary of State must from time to time publish reports about the use
made by the Secretary of State of powers under this Schedule.

(2) 20Each report must, in particular, specify—

(a) the cases in which a monetary penalty was imposed, or an
enforcement costs recovery notice was served, during the period to
which the report relates (other than cases in which the penalty or
notice was overturned on appeal);

(b) 25the cases in which liability for a monetary penalty was discharged as
mentioned in paragraph 2(2);

(c) the cases in which an enforcement undertaking was accepted.

(3) This paragraph does not require the Secretary of State to include in a report
any information which, in the Secretary of State’s opinion, it would be
30inappropriate to include on the ground that doing so—

(a) would or might be unlawful, or

(b) might adversely affect any current investigation or proceedings.

Disclosure of information

16 (1) Information may be disclosed to the Secretary of State for the purpose of the
35exercise by the Secretary of State of any powers conferred on the Secretary
of State under or by virtue of this Schedule if the information is held by or
on behalf of—

(a) a police officer or an officer of Revenue and Customs,

(b) the Crown Prosecution Service,

(c) 40a procurator fiscal, or

(d) the Public Prosecution Service for Northern Ireland.

(2) It does not matter for the purposes of sub-paragraph (1) whether the
information was obtained before or after this Schedule comes into force.

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(3) Subject to sub-paragraphs (4) and (5), the disclosure of information under
this paragraph is not to be taken to breach any restriction on the disclosure
of information (however imposed).

(4) Nothing in this paragraph authorises a disclosure of information which
5would contravene the data protection legislation (but in determining
whether a disclosure would do so, take into account the power conferred by
this paragraph).

(5) Nothing in this paragraph authorises a disclosure of information which
would contravene Parts 1 to 7 or Chapter 1 of Part 9 of the Investigatory
10Powers Act 2016.

(6) This paragraph does not affect a power to disclose information that exists
apart from this paragraph.

Part 6 Interpretation

17 15In this Schedule—

  • “enforcement costs recovery notice” has the meaning given by
    paragraph 6(2);

  • “enforcement undertaking” has the meaning given by paragraph
    5(1)(b);

  • 20“monetary penalty” has the meaning given by paragraph 1(2);

  • “supplementary regulations” has the meaning given by paragraph 9.

Section 36

SCHEDULE 2 Offence of breaching provisions in the Medical Devices Regulations 2002

Part 1 25Offence

1 In the Medical Devices Regulations 2002 (S.I. 2002/618S.I. 2002/618), after regulation 60
insert—

60A Offence of breaching certain provisions

(1) A person commits an offence if the person contravenes a prohibition
30or fails to comply with a requirement in a provision of the
regulations listed in the Schedule to these Regulations inserted by
Schedule 2 to the Medicines and Medical Devices Act 2020.

(2) A person guilty of an offence under paragraph (1) is liable—

(a) on summary conviction in England and Wales, to
35imprisonment for a term not exceeding 51 weeks, to a fine or
to both;

(b) on summary conviction in Scotland or Northern Ireland, to
imprisonment for a term not exceeding 6 months, to a fine not
exceeding level 5 on the standard scale or to both.

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(3) In relation to an offence committed before the coming into force of
section 281(5) of the Criminal Justice Act 2003, the reference in
paragraph (2)(a) to 51 weeks is to be read as a reference to 6 months.

60B Defence of due diligence

(1) 5It is a defence for a person charged with an offence under regulation
60A(1) to show that the person took all reasonable steps and
exercised all due diligence to avoid commission of the offence.

(2) If in any case the defence provided by paragraph (1) involves an
allegation that the commission of the offence was due to—

(a) 10an act or default of another person, or

(b) reliance on information given by another person,

the defendant is not, without leave of the court, entitled to rely on
that defence unless the requirement in paragraph (3) is satisfied.

(3) The requirement is that at least 7 clear days before the hearing the
15defendant has served on the prosecutor a notice giving such
information identifying or assisting in the identification of that other
person as was then in the defendant’s possession.

(4) A defendant is not entitled to rely on the defence provided by
paragraph (1) by reason of the defendant’s reliance on information
20supplied by another person unless the defendant shows that it was
reasonable in all the circumstances to rely on the information, having
regard in particular to—

(a) the steps which the defendant took or might reasonably have
taken to verify the information, and

(b) 25whether the defendant had any reason to disbelieve the
information.

(5) In the application of this regulation to Scotland, references to the
defendant are to be read as references to the accused.

60C Offences by bodies corporate

(1) 30Where an offence under regulation 60A(1) committed by a body
corporate or a Scottish partnership is proved to have been committed
with the consent or connivance of, or to be attributable to any neglect
on the part of, an officer, the officer (as well as the body corporate or
partnership) commits the offence and is liable to be proceeded
35against and punished accordingly.

(2) In relation to a body corporate, “officer” means—

(a) a director, manager, secretary or other similar officer of the
body, or

(b) a person purporting to act in any such capacity.

(3) 40In paragraph (2)(a), “director”, in relation to a body corporate whose
affairs are managed by its members, means a member of the body
corporate.

(4) In relation to a Scottish partnership, “officer” means—

(a) a partner, or

(b) 45a person purporting to act as a partner.”

Medicines and Medical Devices BillPage 35

Part 2 Provisions

2 In the Medical Devices Regulations 2002 (S.I. 2002/618S.I. 2002/618), after the last
Schedule insert, with the appropriate number, the following Schedule—

Regulation 60A

“Schedule 5Provisions breach of which is an offence under regulation 60A

The regulations referred to in regulation 60A(1) are—

Regulation Description
8(1), (2) Essential requirements for general medical devices
10(1) to (5) CE marking of general medical devices
11 10CE marking of general medical devices within scope of more
than one Directive
13(1) to (4) Procedures for affixing a CE marking to general medical devices
14(1), (2), (5) Procedures for systems and procedure packs, and for devices to
be sterilised before use
15 15Procedures for custom-made general medical devices
16(1), (4), (7),
(10)
Procedures for general medical devices for clinical investigation
17(1), (2) Manufacturers etc and conformity assessment procedures for
general medical devices
19 20Registration of persons placing general medical devices on the
market
22 Essential requirements for active implantable medical devices
24 CE marking of active implantable medical devices
25 CE marking of active implantable medical devices within scope
25of more than one Directive
27 Procedures for affixing a CE marking to active implantable
medical devices
28 Procedures for custom-made active implantable medical devices
29(1), (3), (6),
(7), (9)
Procedures for active implantable medical devices for clinical
30investigations
30(1) Manufacturers etc and conformity assessment procedures for
active implantable medical devices
34 Essential requirements for in vitro diagnostic medical devices

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Regulation Description
36(1) to (5) CE marking of in vitro diagnostic medical devices
37 CE marking of in vitro diagnostic medical devices within scope
of more than one Directive
38 5In vitro diagnostic medical devices not ready for use
40 Procedures for affixing a CE marking to in vitro diagnostic
medical devices
41(1), (2), (3) Manufacturers etc and conformity assessment procedures for in
vitro diagnostic medical devices
43 10Devices for performance evaluation
44 Registration of manufacturers etc of in vitro diagnostic medical
devices and devices for performance evaluation
50(1)(a) and
(b), (2), (3)
Products incorrectly marked with a notified body or conformity
assessment body number
51(1), (2) 15Products incorrectly marked with a CE marking”