Schedules Schedule 2: Medical Devices: Civil Sanctions Part 2: Enforcement Undertakings
Part 2 outlines "enforcement undertakings". These provisions allow a person to offer to take certain action within a specified time as a result of the Secretary of State suspecting (on reasonable grounds) that they have committed an offence under section 28 or under regulation 60A of the MDR. The action taken can either be to ensure the offence does not occur again, or as set out in the supplementary regulations. The Secretary of State has the power to accept an enforcement undertaking.
	Paragraph 5(2) provides that the person cannot be convicted of an offence, or subject to a monetary penalty, in relation to the action that led to the offer of the enforcement undertaking, unless they have failed to comply with the undertaking.