Part 4: Medical Devices Chapter 3: Enforcement Section 21: Compliance notices
Section 21 gives the "enforcement authority" the power to issue a compliance notice on a person involved in marketing or supplying a medical device. This means that a compliance notice can be served on any actor in the supply chain. This kind of notice can only be issued where the relevant person is reasonably suspected of not complying with a medical devices provision (as defined under section 17(2)). If the person reasonably suspected of non-compliance is a manufacturer based overseas, the notice could also be issued to their UK responsible person or, if the device has been placed on the NI market and the overseas manufacturer has designated an authorised representative based in NI, that authorised representative.
	A compliance notice must –
identify the relevant medical devices provision with which the person is suspected not to be complying,
explain the grounds for suspicion of non-compliance,
require the person to comply with the relevant provision within a specified time period,
require the person to provide evidence of compliance to the enforcement authority within a specified time period,
require the person to take other necessary measures to ensure compliance that may be specified, within a specified period.
	Subsection (3) is self-explanatory.
	Subsection (4) provides that the enforcement authority may vary or revoke a compliance notice.
	Subsection (5) provides that if the person mentioned in subsection (1) is a manufacturer, this notice can either be served on them, or their representative (or both).
Example (9): Definition of Manufacturer
A manufacturer is defined in regulation 2 of the MDR and means –
(a) as the person with responsibility for the design, manufacture, packaging and labelling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party; or
(b) any other person who assembles, packages, processes, fully refurbishes or labels one or more ready-made products or assigns to them their intended purpose as a device with a view to their being placed on the market under his own name, apart from a person who assembles or adapts devices already on the market to their intended purpose for an individual patient.