Schedules Schedule 2: Medical Devices: Civil Sanctions Part 5: General and Supplemental Guidance as to enforcement
Paragraph 13 requires the Secretary of State to prepare and publish guidance with regard to enforcement and civil sanctions. More specifically, this guidance must cover the sanctions that may be imposed if a person commits an offence, the action the Secretary of State may take, and the circumstances in which action is likely to be taken.
	Sub-paragraph (2) provides that the guidance must include information on the circumstances when, and the manner in which, the Secretary of State will impose a monetary penalty.
	Sub-paragraph (3) similarly provides the guidance must include information on the Secretary of State’s powers to issue an enforcement costs recovery notice, and relevant information alongside this.
	Similarly, sub-paragraph (4) provides that guidance must provide further information on the Secretary of State’s power to accept an enforcement undertaking.
	Sub-paragraph (5) provides that the Secretary of State can revise the guidance published under this paragraph where it is appropriate to do so and must then publish the revised guidance.
	Sub-paragraph (6) outlines who the Secretary of State must consult with before publishing any new or revised guidance.
	Sub-paragraph (7) provides that the Secretary of State must have regard to the guidance whilst exercising any of the powers outlined in this Schedule.