Schedules Schedule 2: Medical Devices: Civil Sanctions Part 4: Power to Make Supplementary Provision etc by Regulations Enforcement undertakings
Paragraph 11 sets out the matters relating to enforcement undertakings that can be set out in supplementary regulations, being:
how a person can enter into an undertaking;
the terms of an undertaking;
when/how the Secretary of State can publish an undertaking;
variation of an undertaking;
what constitutes compliance with an undertaking;
how the Secretary of State can monitor compliance;
how the Secretary of State can issue a certification of compliance for the undertaking;
the ability to appeal against the Secretary of State’s decision to refuse certification of compliance;
provision that where a person has given inaccurate, misleading or incomplete information in relation to an undertaking, that person is to be regarded as non-compliant;
provision that where an enforcement undertaking has only been partly complied with, the partial compliance should be taken into account when considering imposing any sanctions to be imposed on that person.