Part 4: Medical Devices Chapter 1: Regulations: General Section 16: Manufacture, marketing and supply
Section 16 lists matters relating to the marketing of medical devices that regulations made under section 16(1) can cover. This list is exhaustive.
	Subsection (1)(a) allows provision to be made in relation to the requirements that must be met before a medical device can be placed on the market, supplied put into service. This includes the characteristics of medical devices such as materials, design, manufacture and packaging, and the requirements for those involved in the marketing and supply of devices, including (but not limited to) the manufacturer.
	Subsection (1)(b) allows provision to be made in relation to the assessment of whether requirements are met.
	Subsection (1) (c) allows provision to be made in relation to who may carry out such assessments, including provision allowing for the appointment of a specified person or persons, UK-based or not, to assess and certify medical devices and assess whether they meet all relevant requirements and confirm they have been met.
	Subsection (1)(d), (e) and (f) cover the assessment of requirements and confirmation that requirements are met. For example, assessments of whether or not requirements have been met, and to what standard, as well as which persons (in addition to those appointed under 1(c)) can confirm that such requirements are met. Subsection (1)(e) relates to the making of declarations that requirements are met. These requirements could include specific technical requirements relating to devices, as well as requirements placed on those who manufacturer them (for instance, the requirement to maintain a quality management system).
	Subsection (1)(g) allows provision to be made in relation to the packaging and labelling of medical devices as well as the information and instructions that accompany them. Regulations made relying on this provision could, for instance, specify what information should be included on the label and/or packaging of a device, and specify what should be included in instructions for use that accompany the device.
	Subsection (1)(h) covers registration of devices, their manufacturers or suppliers, including what information must be entered in a register. The power could be used to, by regulations, provide that information entered on a register be made available to the public.
Example (6): Registration of Devices
New registration requirements are being phased in for medical devices. As a result, if you place certain medical devices on the market, then from a certain date you, your appointed UK responsible person (or, if you are placing devices on the NI market, and have a NI based authorised representative, your authorised representative) must register with the MHRA. These requirements differ depending on the class of device being placed on the market, and whether or not the device is being placed on the GB or NI market.
	Subsection (1)(i) allows provision to be made in relation to the investigation and evaluation of the safety, performance and clinical effectiveness of medical devices.
	Subsection (1)(j) allows provision to be made in relation to surveillance, that is, the monitoring of the medical devices market to ensure that devices comply with regulatory requirements.
	Subsection (2) relates to what provisions may be included in regulations made under section 15(1) and relying on subsection (1)(a). It provides that provisions concerning relevant requirements, may, among other things, refer to international agreements or standards for marketing or supplying medical devices.