The Medicines and Healthcare Regulatory Agency (MHRA) has updated its guidance on determining if a product should be classed as a medicine or medical device. They say,
“Some products are hard to distinguish from a medicine or a medical device, for example cosmetics, food supplements or biocidal products. These products are called borderline products until their status has been decided.
MHRA determines whether a product falls within the definition of a medicine – ‘medicinal product’ or a medical device and provides information on whether a product is a medicine or a medical device or not.”
Some products fall easily into this borderline group, such as cosmetics, food supplements, herbal products and some devices or equipment.
According to MHRA,
“A medicinal product is:
- Any substance or combination of substances presented as having properties of preventing or treating disease in human beings
- Any substance or combination of substances that may be used by or administered to human beings with a view to restoring, correcting or modifying a physiological function by exerting a pharmacological, immunological or metabolic action, or making a medical diagnosis”
Usually, a manufacturer will determine the status of their product for themselves, using the regulation and advice from sites such as MAP MedTech, but MHRA is required to make judgments when either a manufacturer is unsure, or when they receive a complaint that a product is not appropriately categorised. MHRA make their judgment based on:
- The claims about what the product does (explicit and implicit)
- The pharmacological, metabolic or immunological properties of the ingredients (this includes any herbal ingredients)
- The primary intended purpose of the product
- Whether there are any similar licensed or registered products on the market
- How it is presented to the public through labelling, packaging, promotional literature and advertisements