Part 4: Medical Devices Chapter 3: Enforcement
This Chapter sets out a new, consolidated enforcement regime for medical devices. The Chapter confers powers on the enforcement authority to issue enforcement notices in certain circumstances, in order to achieve compliance with the medical devices regulatory framework, and to address health and safety risks posed by non-compliant devices.
	"Enforcement authority" is defined in section 42(2). In relation to all medical devices, this is the Secretary of State, and in relation to devices that are consumer products, it also means a local weights and measures authority in Great Britain/district council in Northern Ireland.
Example (8): Enforcement
The Medical Devices Regulations 2002 (SI 2002/618) (MDR) are currently safety regulations under section 11 of the Consumer Protection Act 1987. As such, the Secretary of State has a duty to enforce these breaches under section 27(1) of that Act (as applied by regulation 61(2) of the MDR). This means that the Secretary of State can investigate any business activity that is covered by the MDR using the powers of entry set out in Schedule 5 (investigatory powers etc) to the Consumer Rights Act 2015 (see paragraphs 3, 9(1)(a) and 10 of Schedule 5 to the Consumer Rights Act 2015). The Consumer Protection Act 1987 also contains powers of entry which are very similar in nature to those contained in Schedule 5.In the majority of circumstances, the MHRA aims to provide high level guidance on how manufacturers can comply with the MDR and what they need to do to ensure that they are not putting members of public at risk unnecessarily.
However, it has various powers to drive compliance, restrict market access or prosecute where required.
These various powers are currently spread across the MDR, Consumer Protection Act 1987 and the General Product Safety Regulations 2005. The interplay between the enforcement powers (and the powers of entry outlined above) contained in different legislation is complex and unclear. Consolidating powers will significantly improve MHRA's ability promote and support industry compliance. It will also provide industry with clarity and certainty regarding legal obligations. Further, it will enable MHRA to take swift and effective enforcement action only when circumstances warrant it.