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.
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.
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.