Consolidating and expanding medical devices enforcement provisions
Chapter 3 of Part 4 of the Act seeks to consolidate the enforcement regime for medical devices and provides the Secretary of State with the ability (see Schedule 2) to impose civil sanctions as an alternative to criminal prosecution. Chapter 4 of Part 4 provides the Secretary of State with a new information sharing gateway.
	Currently, the Secretary of State’s powers to enforce compliance with medical device regulation can be found in numerous pieces of legislation, including the Medical Devices Regulations 2002 (SI 2002/618), the Consumer Protection Act 1987 (c. 43), the Consumer Rights Act 2015 (c. 15) and the General Product Safety Regulations 2005 (SI 2005/1803).
	The structure of these legislative powers does not enable the MHRA to operate efficiently or provide clarity to UK and international manufacturers on the operation of its enforcement regime. For instance, currently, the Secretary of State has enforcement powers to restrict the supply of devices in both the Medical Devices Regulations 2002 and the CPA (see regulation 63 (restriction notices) of the Medical Devices Regulations 2002 and sections 13 (prohibition notices and notices to warn) and 14 (suspension notices) of the CPA), and it is not clear in what circumstances each power should be used.
	The link to the CPA also means that the sanction for failing to comply with medical device regulations is the general offence of breaching safety regulations contained in section 12 (offences against the safety regulations) of the CPA. This offence contains four "limbs" and determining whether or not a failure to comply with a provision of the Medical Devices Regulations 2002 is an offence involves an analysis of whether the provision fits within any of the "limbs". This creates uncertainty for both the Secretary of State and industry.
	The Act seeks to remedy this uncertainty by creating a clearer consolidated enforcement regime. The key features of this new regime are:
the disapplication of the CPA, and amendments to the Medical Devices Regulations 2002, so that powers to issue enforcement notices are contained solely in this Act (meaning that they are more specific to medical devices); and
the creation of a bespoke criminal offence, which clarifies which contraventions of the Medical Devices Regulations 2002 could result in prosecutions (note: this does not criminalise new behaviour but for the most part reflects the existing position under section 12 of the CPA in a more transparent and focussed manner). This offence will retain the existing maximum penalties under section 12 of the CPA.
	The Act also introduces new powers to impose civil sanctions on those who have breached the Medical Devices Regulations 2002, as an alternative to criminal prosecution. In particular, the Act provides the Secretary of State with powers to impose a monetary penalty on a person (where the Secretary of State is satisfied beyond reasonable doubt that the person has committed an offence) and accept an enforcement undertaking (where the Secretary of State has reasonable grounds to suspect a person has committed an offence and that person offers the undertaking).
	The Act also provides the Secretary of State with new powers to share information it holds about medical devices in limited circumstances. These include a power to share medical device information with the public where necessitated by safety concerns and a power to share information with persons providing services or exercising functions in relation to medical devices. Such powers are subject to data protection legislation, and also to provisions which place restrictions on the disclosure of commercially sensitive information. It also includes a power to share information internationally with certain persons (such as other regulators) further to international arrangements about the regulation of medical devices.