How MHRA approaches products that sit on the boundary between medical devices and other regulatory frameworks — medicines, cosmetics, biocides — and how drug-device combination products are regulated under the UK Medical Devices Regulations 2002.
The legal definition of a medical device under the UK Medical Devices Regulations 2002 (SI 2002/618), the intended purpose principle, mode of action exclusion, and how to determine whether your product requires MHRA compliance.
The legal definition of an in vitro diagnostic medical device (IVD) under Part III of the UK Medical Devices Regulations 2002, IVD classification categories, and how IVD regulation differs from general medical devices.
Products that are not medical devices under the UK Medical Devices Regulations 2002 — exclusions, borderline categories, lifestyle and wellness products, and how MHRA approaches products on the boundary of the definition.