Part 5 General and Supplemental
Medicines and Medical Devices Act 2021 (2021 c 3) | Legislation

Part 5 General and Supplemental

Guidance 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 28[, regulation 60A of the Medical Devices Regulations 2002 or regulation 23 of the Medical Devices (Northern Ireland Protocol) Regulations 2021;]

(b)     the 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 power 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 for 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

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