Part 4: Medical Devices Chapter 1: Regulations: General Section 15: Power to make regulations about medical devices
Section 15(1) confers a delegated power to amend or supplement the Medical Devices Regulations 2002 (MDR).
	The power is targeted in its scope because regulations made under section 15(1) may only contain provision relating to the matters specified on the face of the Act at sections 16, 17 and 18. The lists of matters specified in sections 16 to 18 are exhaustive, meaning that only regulatory changes that fall within these descriptions may be made under this power.
	The delegated power is exercisable by the Secretary of State. "Secretary of State" is defined in the Interpretation Act 1978 to mean any Secretary of State and in practice it would be the Secretary of State for Health and Social Care exercising this power.
	Section 15(2) places a duty on the Secretary of State to have the overarching objective of safeguarding public health when making regulations using the power under section 15(1).
	Section 15(3) provides that when considering whether regulations would contribute to this objective, the Secretary of State must at least have regard to the three factors listed in (a) to (c). These are: the safety of medical devices, the availability of medical devices and the likelihood of the UK being seen as a favourable place in which to carry out research relating to medical devices, develop medical devices, and manufacture or supply medical devices. Other factors may of course be relevant to any decision to exercise the delegated power.
	Section 15(4) provides that the Secretary of State may make regulations under section 15(1) that may have an impact on the safety of medical devices only if the authority considers that the benefits of doing so outweigh the risks.