Schedules Schedule 2: Medical Devices: Civil Sanctions Part 1: Monetary Penalties Notices, representations and appeals etc
Paragraph 2 provides that the Secretary of State must notify a person on whom he is planning to impose a monetary penalty before doing so. That notice must give the person the opportunity to discharge their liability by paying less than, or an equal amount to, the penalty. The person will then also have the opportunity to write to, or object to the Secretary of State regarding the penalty. Following this, the Secretary of State must then decide whether or not to proceed with the penalty.
	Paragraph 2(5) provides that the Secretary of State cannot issue a monetary penalty if he is no longer satisfied with the reasons for doing so.
	Paragraph 2(6), sets out the circumstances in which the person who has been issued with the penalty may appeal. Any such appeal is to the First Tier Tribunal. The First Tier Tribunal is made up of 7 chambers which settles legal disputes and is structured around particular areas of law.
	Paragraph 2(8) provides that the Tribunal must allow the appeal if the appellant claims they did not commit an offence, unless they believe beyond reasonable doubt that they did. This is the same standard of proof as required by a criminal offence.