How the Medicines and Healthcare products Regulatory Agency (MHRA) makes decisions on what is a medicine or medical device (borderline products).
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.
Types of borderline products
The types of products which may fall in to the borderline category include:
- food products, including, in particular, food supplements
- herbal products
- medical devices
- machinery/laboratory equipment
There is also a borderline between medicinal products and medical devices. In these cases it will be the claims being made and the mode of action that will decide which regulatory regime will apply.
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
You can find more detailed information in Regulation 2 of the Human Medicines Regulations.
Food supplements that contain familiar substances like vitamins, amino acids or minerals are generally subject to food safety and food labelling legislation rather than medicines control. You can get advice on food and cosmetics from the Trading Standards Institute.
MHRA decides whether the claims that are made or the active substance(s) present would mean that the product is regarded to be a medicinal product.
The inclusion of herbal or ‘natural’ ingredients does not exclude a product from being a medicinal product. MHRA takes the same factors into account when deciding the status of a product with herbal ingredients.
How we decide if a product is a medicine
MHRA decides whether a product is a medicine when:
- the manufacturer is not sure if their product is a medicine or not, and they come to MHRA for advice
- MHRA receives a complaint that a product is being marketed as a medicine but does not have a marketing authorisation (formerly a product licence)
We look at:
- 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
See National Archives.. Previous final determinations are available on the
Borderline medical devices
Medical devices fall into 1 of 3 categories, as each type is governed by a different EU directive:
- medical devices – covered by the Medical Devices Directive (Directive 93/42/EEC)
- in vitro diagnostic medical devices – covered by the In Vitro Diagnostic Medical Devices (Directive 98/79/EC)
- active implantable medical devices – covered by the Active Implantable Medical Devices (Directive 90/385/EEC)
MHRA can give advice if you are not sure which category your device fits into.
You should not assume that if your product is considered a medical device in countries outside the EU that it will be a medical device in the EU as well.
Decisions about whether a product is a medical device are based on the stated intended purpose of the product and its mode of action.
If the product is a medical device, the principal intended action is fulfilled by physical means.
Getting advice about your product
You can find detailed advice here in our. You should read this document before contacting MHRA.
Use our borderline advice form form to request information on a medicine if you don’t find the information you need in our guidance document. Email the completed form and attachments to firstname.lastname@example.org.
MHRA will only respond to enquiries about up to 6 products at a time.
Borderline medical devices
If your enquiry is about the regulatory route for a medical device you should email Devices.email@example.com.
Medical device borderlines