Labelling requirements
The labelling requirements for medical devices placed on the GB market under UK MDR 2002 Schedule 1, Essential Requirement 18 — mandatory label elements, UKCA mark placement, UKRP details, language requirements, and IFU obligations.
Advertising rules
The rules governing advertising and promotion of medical devices in the UK — which claims are permitted, the prohibition on advertising unregistered devices, the role of MHRA and the ASA, and the special rules for IVDs and implantable devices.
Permitted & prohibited claims
What claims are permitted and prohibited in UK medical device labelling, IFU, and advertising — including performance claims, clinical outcome claims, comparison claims, and the prohibition on claims that exceed the device's registered intended purpose.