UK – Borderline products: how to tell if your product is a medical device and which risk class applies

How the MHRA makes decisions on when a product is a medical device (borderline products), and which risk class should apply to a medical device.

Some products are hard to distinguish from a medical device, for example products that might be medicines, cosmetics, food supplements, biocidal products or personal protective equipment. These products are called borderline products until their status has been decided.

The MHRA determines whether a product falls within the definition of a medical device and provides information on whether a product is a medical device or not. The MHRA also determines whether a product is a medicine or not.

For products which are medical devices, MHRA also considers the risk classification applied to the device and whether this is appropriate…