MHRA Updates Guidance on Borderlines with Medical Devices and Other Products in Great Britain
MHRA guidance on medical device borderlines in Great Britain, covering intended purpose, UKCA scope and manufacturer considerations.
MHRA updates guidelines on the classification of borderline products with medical devices in the UK
The MHRA has published a new version of the guide to classifying borderline products with medical devices. This update clarifies the criteria used in the UK to determine whether or not a product is a medical device, with a direct impact on cosmetic products, food supplements and others with therapeutic claims. If you operate in this market, it is essential to review the declared purposes, clinical evidence and regulatory framework.