Medicines and Medical Devices Bill (HC Bill 90)

Medicines and Medical Devices BillPage 10

17 Suspension notices

(1) This section applies where the enforcement authority considers that it may be
necessary to restrict the availability of a medical device in order to protect
health or safety.

(2) 5The enforcement authority may serve on a person a notice (“a suspension
notice”) prohibiting the person from doing the following except with the
consent of the enforcement authority—

(a) supplying the medical device;

(b) offering to supply it;

(c) 10agreeing to supply it;

(d) exposing it for supply;

(e) possessing it for supply.

(3) A suspension notice must—

(a) set out the enforcement authority’s grounds for considering that it may
15be necessary to restrict the availability of the medical device to which
the notice relates, and

(b) specify the period for which the notice has effect.

(4) The period may not end more than 6 months after the day on which the
suspension notice is served.

(5) 20The enforcement authority may—

(a) reduce the period for which a suspension notice has effect, or

(b) revoke a suspension notice.

18 Safety notices

(1) The enforcement authority may serve on a person a notice (“a safety notice”)
25imposing on the person prohibitions or requirements that the enforcement
authority considers necessary to restrict the availability of a medical device in
order to protect health or safety.

(2) The prohibitions that may be imposed include prohibitions on doing any of the
following except with the consent of the enforcement authority—

(a) 30supplying the medical device;

(b) offering to supply it;

(c) agreeing to supply it;

(d) exposing it for supply;

(e) possessing it for supply.

(3) 35The requirements that may be imposed include requirements to—

(a) publish, at the person’s expense, one or more warnings, in such form
and manner and on such occasions as may be specified in the notice,
about a medical device which the person supplies or has supplied;

(b) organise or cooperate with the enforcement authority in organising in
40such manner as may be specified in the notice, so far as reasonably
practicable, the recall of the device to the person or to any other person
identified in the notice.

(4) But a requirement to organise or cooperate in the recall of a device may be
imposed on a person in reliance on subsection (3)(b) only if the enforcement

Medicines and Medical Devices BillPage 11

authority is satisfied that no alternative requirement would sufficiently protect
health or safety as mentioned in subsection (1).

(5) A safety notice must set out the grounds on which the enforcement authority
considers it necessary to restrict the availability of the medical device to which
5the notice relates.

(6) The enforcement authority may vary or revoke a safety notice.

(7) Subject to subsection (8), the enforcement authority may not serve a safety
notice on a person or vary a safety notice unless the enforcement authority has
given the person a reasonable opportunity to make representations about the
10need for, and the contents of, the proposed safety notice or, as the case may be,
proposed variation.

(8) Subsection (7) does not apply where the enforcement authority considers that
there is an urgent need to make the proposed safety notice or variation in order
to restrict the availability of the medical device to which the proposed safety
15notice or variation relates.

19 Information notices

(1) This section applies where the enforcement authority considers that a person
has information which the enforcement authority needs for the purpose of
deciding whether to—

(a) 20serve or revoke a compliance notice,

(b) serve or revoke a suspension notice, or

(c) serve, vary or revoke a safety notice.

(2) The enforcement authority may serve on the person a notice (an “information
notice”) requiring the person—

(a) 25to disclose to the enforcement authority information specified in the
notice, within a period specified in the notice, or

(b) to produce records specified in the notice at a time and place specified
in the notice, and to permit a person appointed by the enforcement
authority to take copies of the records at that time and place.

(3) 30A period specified in reliance on subsection (2)(a) must be a period of at least
28 days beginning with the day on which the notice is served.

(4) A time specified in reliance on subsection (2)(b) must be at least 28 days after
the notice is served.

(5) The enforcement authority may vary or revoke an information notice.

20 35Applications to set notices aside etc

(1) A person affected by a compliance, suspension or safety notice may apply to
the appropriate lower court (see section 37)—

(a) to set the notice aside, or

(b) to vary it.

(2) 40A person on whom an information notice has been served may apply to the
appropriate lower court—

(a) to set the notice aside, or

(b) to vary it as mentioned in subsection (8).

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(3) An application under subsection (1) or (2) must be made within the period of
28 days beginning with the day on which the notice to which it relates is—

(a) served, or

(b) varied by the enforcement authority.

(4) 5The appropriate lower court may set aside a compliance, suspension, safety or
information notice only if satisfied—

(a) in respect of a compliance notice, that the person on whom the notice
was served is complying with each medical devices provision with
which the person was suspected not to be complying,

(b) 10in respect of a suspension notice, that the notice is not necessary to
protect health or safety,

(c) in respect of a safety notice, that the prohibitions or requirements in the
notice are not necessary to protect health or safety, or

(d) in respect of an information notice, that the person on whom it has been
15served does not have the information or records specified in the notice.

(5) The appropriate lower court may vary a compliance notice so that it does not
apply in relation to a medical devices provision specified in the notice if
satisfied that the person on whom the notice was served is complying with that
provision.

(6) 20The appropriate lower court may vary a suspension notice by reducing the
period for which it is to have effect if satisfied that the period for which it
would otherwise have had effect was too long.

(7) The appropriate lower court may vary a safety notice by removing a
prohibition or requirement if satisfied that the prohibition or requirement is
25not necessary to protect health or safety.

(8) The appropriate lower court may vary an information notice so that it does not
apply in relation to some of the information or records specified in the notice if
satisfied that the person on whom it was served does not have that information
or those records.

(9) 30An order of the appropriate lower court varying or setting aside a compliance,
suspension, safety or information notice may contain provision delaying the
coming into force of the order pending the making and determination of an
appeal under section 22.

21 Compensation

(1) 35A person affected by a compliance, suspension or safety notice which the
appropriate lower court varies or sets aside may apply to the appropriate
lower court for an order requiring the enforcement authority to pay
compensation in respect of loss or damage caused by reason of the notice.

(2) An application under subsection (1) may be made at the same time as an
40application under section 20(1).

22 Further appeals

(1) A person aggrieved by a decision of the appropriate lower court on an
application under section 20(1) or (2) or section 21(1) may appeal against that
decision to the appropriate appeals court (see section 37).

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(2) An appeal under subsection (1) must be made before the end of the period of
28 days beginning with the day on which the decision to which it relates is
made.

(3) The appropriate appeals court may make any order the court thinks
5appropriate.

Offences

23 Offences

(1) A person commits an offence if the person breaches—

(a) a compliance notice,

(b) 10a suspension notice,

(c) a safety notice, or

(d) an information notice.

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

(a) on summary conviction in England and Wales, to imprisonment for a
15term 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.

(3) In relation to an offence committed before the coming into force of section
20281(5) of the Criminal Justice Act 2003, the reference in subsection (2)(a) to 51
weeks is to be read as a reference to 6 months.

24 Defence of due diligence

(1) It is a defence for a person charged with an offence under section 23(1) to show
that the person took all reasonable steps and exercised all due diligence to
25avoid commission of the offence.

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

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

(b) reliance on information given by another person,

30the defendant is not, without leave of the court, entitled to rely on that defence
unless the requirement in subsection (3) is satisfied.

(3) The requirement is that at least 7 clear days before the hearing the defendant
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
35defendant’s possession.

(4) A defendant is not entitled to rely on the defence provided by subsection (1) by
reason of the defendant’s reliance on information supplied 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) 40the steps which the defendant took or might reasonably have taken to
verify the information, and

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

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

25 Offences by bodies corporate

(1) Where an offence under section 23 committed by a body corporate or a Scottish
5partnership 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 against and punished accordingly.

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

(a) 10a director, manager, secretary or other similar officer of the body, or

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

(3) In subsection (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) 15a partner, or

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

Civil sanctions

26 Civil sanctions

Schedule 1 makes provision for and relating to civil sanctions in relation to the
20commission of offences to do with medical devices.

Forfeiture

27 Forfeiture of medical devices

(1) The enforcement authority may apply to the appropriate lower court (see
section 37) for an order for the forfeiture of a medical device (a “forfeiture
25order”) on the grounds that there has been a contravention of a medical devices
provision in relation to the device.

(2) The appropriate lower court may make a forfeiture order if satisfied that there
has been such a contravention.

(3) The enforcement authority must make reasonable efforts to give notice of the
30application to every person who the enforcement authority thinks is or may be
entitled to the device to which the application relates.

(4) Each person claiming to be entitled to the device may—

(a) appear at the hearing of the application, or

(b) make written representations to the appropriate lower court in relation
35to the application.

(5) If the appropriate lower court decides to make a forfeiture order, the court may
include in the order provision that the device to which the order relates is not
to be forfeited before the appropriate time.

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(6) The enforcement authority may dispose of a forfeited device in whatever way
the enforcement authority thinks appropriate.

(7) But the enforcement authority may not dispose of a forfeited device before the
appropriate time.

(8) 5In this section, the “appropriate time” is—

(a) the end of the period within which an appeal under section 28 may be
made against the order, or

(b) if such an appeal is made, the end of the day on which the appeal is
finally determined or otherwise disposed of.

(9) 10In this section, persons “entitled to a device” are—

(a) if the device has not been seized by the enforcement authority, the
person in possession of the device,

(b) if the device has been seized, the person from whom it was seized, or

(c) if different, any person to whom it belongs.

28 15Appeals against forfeiture decisions

(1) A person claiming to be entitled to a medical device which is subject to a
forfeiture order may appeal against the decision to make the order.

(2) The enforcement authority may appeal against a decision of the appropriate
lower court to refuse an application for a forfeiture order.

(3) 20An appeal under this section is to the appropriate appeals court (see section
37).

(4) An appeal under this section must be made before the end of the period of 28
days beginning with the day on which—

(a) the forfeiture order is made, or

(b) 25the application for a forfeiture order is refused.

(5) Subject to subsection (6), the court hearing the appeal may make any order the
court thinks appropriate.

(6) If an appeal against a decision to make a forfeiture order is allowed, the court
must, if the device to which the order relates has already been forfeited, order
30it to be returned to a person entitled to it.

(7) In this section, persons “entitled to a device” are—

(a) if the device has not been seized by the enforcement authority, the
person in possession of the device,

(b) if the device has been seized, the person from whom it was seized, or

(c) 35if different, any person to whom it belongs.

Recovery of expenses of enforcement

29 Recovery of expenses of enforcement

(1) This section applies where a court—

(a) convicts a person of an offence under section 23 or regulation 60A of the
40Medical Devices Regulations 2002 (S.I. 2002/618S.I. 2002/618) (offence of breaching
certain provisions in the Regulations) in relation to a medical device, or

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(b) makes a forfeiture order under section 27 or 28(5) in relation to a
medical device.

(2) The court may (in addition to any other order it may make as to costs or
expenses) order the person convicted or, as the case may be, a person from
5whom a device is seized or to whom it belongs to reimburse an enforcement
authority for any expenditure which the authority has incurred or may incur—

(a) in connection with any seizure or detention of the device by or on
behalf of the authority, or

(b) in connection with giving effect to the forfeiture order.

10Recall of medical device by enforcement authority

30 Recall of medical device by enforcement authority

(1) This section applies where the enforcement authority considers that—

(a) it is necessary to restrict the availability of a medical device in order to
protect health or safety, and

(b) 15the device has already been supplied or made available to members of
the public.

(2) The authority may take such steps as it considers necessary to organise the
return of the device to the authority or to another person (whether or not it
issues a safety notice under section 18 requiring another person to organise or
20cooperate in organising the recall of the device).

(3) The authority may take steps in reliance on subsection (2) only if satisfied that
no alternative steps that did not involve recalling the device would sufficiently
protect health or safety as mentioned in subsection (1).

Power of officer of Revenue and Customs to detain medical device

31 25Power of officer of Revenue and Customs to detain medical device

(1) An officer of Revenue and Customs may seize an imported medical device and
detain it for not more than two working days in order to facilitate the exercise
by an enforcement authority or an officer of an enforcement authority of a
function under—

(a) 30this Part,

(b) a medical devices provision, or

(c) Schedule 5 to the Consumer Rights Act 2015.

(2) A device seized and detained under this section must be dealt with during the
period of its detention in such manner as the Commissioners for Her Majesty’s
35Revenue and Customs may direct.

(3) In subsection (1), the reference to two working days is a reference to a period
of 48 hours calculated from the time when the device in question is seized but
disregarding so much of any period as falls on a Saturday or Sunday or on
Christmas Day, Good Friday or a day which is a bank holiday under the
40Banking and Financial Dealings Act 1971 in the part of the United Kingdom
where the device is seized.

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32 Offence of obstructing an officer of Revenue and Customs

(1) A person commits an offence if the person intentionally obstructs an officer of
Revenue and Customs who is acting under section 31.

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

(a) 5on summary conviction in England and Wales, to imprisonment 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.

(3) 10In relation to an offence committed before the coming into force of section
281(5) of the Criminal Justice Act 2003, the reference in subsection (2)(a) to 51
weeks is to be read as a reference to 6 months.

Civil proceedings

33 Civil proceedings

(1) 15An obligation imposed by a medical devices provision is to be treated as a duty
owed to any person who may be affected by a breach of the obligation.

(2) Accordingly, a breach of such an obligation gives rise to a right of action for
breach of statutory duty.

(3) Subsections (1) and (2) are subject to—

(a) 20a provision to the contrary in a medical devices provision, and

(b) the defences and other incidents applying to actions for breach of
statutory duty.

CHAPTER 3 Disclosure of information and consequential etc provision

Disclosure of information

34 25Disclosure of information

(1) This section applies in relation to information which the Secretary of State
holds in connection with medical devices.

(2) The Secretary of State may disclose information for the purpose of warning
members of the public about concerns that the Secretary of State has in relation
30to the safety of a medical device.

(3) The Secretary of State may disclose information to a person who provides
services or exercises functions relating to medical devices for the purposes of—

(a) enabling or facilitating the exercise by the Secretary of State of a
function relating to medical devices;

(b) 35enabling or facilitating the exercise by another person of a function
relating to medical devices;

(c) enabling or facilitating the provision of a service relating to medical
devices by another person.

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(4) The Secretary of State may disclose information for the purposes of—

(a) civil proceedings;

(b) criminal investigations or proceedings.

(5) But the Secretary of State may not disclose commercially sensitive information
5in reliance on subsection (2), (3) or (4) unless the Secretary of State—

(a) considers that it is necessary to do so for one or more of the purposes
mentioned in subsection (2), (3) or (4), and

(b) is satisfied that the making of the disclosure is proportionate to what is
sought to be achieved by it.

(6) 10Where information to which this section applies is disclosed to a person in
reliance on subsection (3) or (4), the person may not use or further disclose the
information except—

(a) with the agreement of the Secretary of State and for a purpose
mentioned in subsection (3) or (4), or

(b) 15in accordance with an enactment or order of a court or tribunal.

(7) Except as provided by subsection (8), the disclosure of information in
accordance with this section does not breach—

(a) an obligation of confidence owed by the person making the disclosure,
or

(b) 20any other restriction on the disclosure of the information (however
imposed).

(8) Nothing in this section authorises a disclosure of information which—

(a) contravenes the data protection legislation (but in determining whether
a disclosure would do so, take into account the powers conferred by
25this section), or

(b) is prohibited by any of Parts 1 to 7 or Chapter 1 of Part 9 of the
Investigatory Powers Act 2016.

(9) In this section—

  • “commercially sensitive information” means commercial information
    30whose disclosure the Secretary of State thinks might significantly harm
    the legitimate business interests of the undertaking to which it relates;

  • “function” means power or duty.

35 Offence relating to information

(1) A person to whom information is disclosed under section 34 commits an
35offence if the person uses or discloses that information in contravention of
subsection (6) of that section.

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

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

(b) 40on summary conviction in Scotland or Northern Ireland, to
imprisonment for a term not exceeding 6 months, to a fine not
exceeding level 5 of the standard scale or to both.

(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 subsection (2)(a) to 51
45weeks is to be read as a reference to 6 months.

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Consequential etc provision

36 Consequential and supplementary provision

(1) In the Consumer Protection Act 1987—

(a) in section 11 (safety regulations), in subsection (7), at the end insert—

(e) 5medical devices.”;

(b) in section 19 (interpretation of Part 2), in subsection (1), at the
appropriate place insert—

  • ““medical device” has the same meaning as in Part 3 of the
    Medicines and Medical Devices Act 2020;”.

(2) 10In the Consumer Rights Act 2015, in Schedule 5 (investigatory powers etc)—

(a) in paragraph 10 (enforcer’s legislation: duties and powers mentioned in
paragraph 9(1)(a)), at the appropriate place insert “regulation 61 of the
Medical Devices Regulations 2002 (S.I. 2002/618S.I. 2002/618)”;

(b) in the table in paragraph 11 (enforcer’s legislation), at the end insert—

“The Secretary of State, a
local weights and measures
authority in Great Britain or
a district council in
Northern Ireland
15Regulations made under section 12(1) of the
Medicines and Medical Devices Act 2020


The Secretary of State, a
local weights and measures
authority in Great Britain or
a district council in
Northern Ireland
20Chapter 2 of Part 3 of the Medicines and Medical
Devices Act 2020”


(c) 25in paragraph 19 (exercise of powers in Part 4), after sub-paragraph (7)
insert—

(7A) A domestic enforcer may exercise the power in paragraph
30A (power to decommission or switch off fixed medical
devices)—

(a) 30if an officer of the enforcer reasonably suspects a
breach of the Medical Devices Regulations 2002 (S.I.
2002/618) or of regulations made under section 12(1)
of the Medicines and Medical Devices Act 2020, and

(b) for the purpose of ascertaining (by means of testing or
35otherwise) whether there has been such a breach.”;

(d) after paragraph 30 insert—

30A (1) The power in sub-paragraph (2) is available to an officer of a
domestic enforcer acting pursuant to the duty in regulation
61(1A) or (1B) of the Medical Devices Regulations 2002 (S.I.
402002/618) or to a duty in regulations made under section
12(1) of the Medicines and Medical Devices Act 2020.

(2) The officer may decommission or switch off any medical
device to which the Medical Devices Regulations 2002 apply
which is installed at a given location.”;

(e) 45in paragraph 31 (power to break open container etc)—