PART 4 U.K.Medical devices

CHAPTER 3 U.K.Enforcement

Offences U.K.

28 Offences U.K.

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

(a) a compliance notice,

(b) a 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 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) 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 weeks is to be read as a reference to 6 months.

Commencement Information

I1 S. 28 in force at 26.5.2021 by S.I. 2021/610, reg. 2(a)

29 Defence of due diligence U.K.

(1) It is a defence for a person charged with an offence under section 28(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 proceedings for such an offence 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,

the 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 of the proceedings 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 defendant'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) the 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.

(5) In the application of this section to Scotland—

(a) references to the defendant are to be read as references to the accused, and

(b) the reference in subsection (3) to “the hearing of the proceedings” is to be read as a reference to “the trial diet”.

Commencement Information

I2 S. 29 in force at 26.5.2021 by S.I. 2021/610, reg. 2(a)

30 Offences by bodies corporate U.K.

(1) Where an offence under section 28 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 against 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) 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) a partner, or

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

Commencement Information

I3 S. 30 in force at 26.5.2021 by S.I. 2021/610, reg. 2(a)