Decide if your product is a medicine or a medical device
How the Medicines and Healthcare products Regulatory Agency (MHRA) makes decisions on what is a medicine or medical device (borderline products).
Overview
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.
The 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:
- cosmetics
- food products, including, in particular, food supplements
- herbal products
- medical devices
- biocides
- 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.
Borderline medicines
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.
The 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. The 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 the MHRA for advice
- The 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 See . Previous final determinations are available on the National Archives.
See
Complaints
All referrals and complaints about potential breaches of The Human Medicines Regulations 2012 are reviewed and dealt with by the MHRA. As we receive a high volume of referrals, it is necessary to consider them on the basis of priority, the highest of which is where there is a perceivable risk to the health and safety of consumers. As a consequence, it is not possible to take immediate action in all cases.
In the majority of cases we aim to resolve issues through voluntary compliance by the relevant company. It cannot be assumed that a product found to be in breach of medicines regulations will always be removed from sale as a result of our action. In some cases, issues can be resolved by amending product details such as claims or product formulations.
Generally, investigations need to be conducted with commercial confidentiality in mind and for that reason, it is not always possible for us to provide feedback on cases. It is also not possible to say how long investigations will take to reach a conclusion as this is dependent on a number of factors, several of which can delay progress. This will apply in particular where voluntary compliance is not achieved, or where investigations need to be escalated to a position of potential prosecution. Although it may appear that nothing is being done, this is not the case. In such circumstances, there is a risk that cases could be prejudiced by disclosures.
In some instances, the MHRA receives referrals about products that are not deemed to be in breach of medicines regulations, or which may be more appropriately dealt with by another authority such as Trading Standards. This may be where more than one set of regulations is being breached. We will either recommend the referrer contacts the appropriate authority themselves, or in some circumstances, may forward the complaint on their behalf. The MHRA will not be able to chase up referrals on behalf of a third party where they have been forwarded to another authority.
The MHRA has authority to administer and enforce regulations relating to medicinal products that are sold, supplied or advertised from within the UK. Products that are sold, supplied or advertised by non-UK companies from outside of the UK and exported directly to consumers in the UK are investigated, but may fall outside of the MHRA’s legal jurisdiction.
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)
The 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
Borderline medicines
You can find detailed advice here in our . You should read this document before contacting the MHRA.
You can obtain a regulatory opinion on the status of a product you are planning to sell in the UK by providing the appropriate details using the Medicines Borderline Advice Form. The MHRA will only respond to a maximum of 4 product enquiries at a time.
Borderline medical devices
If your enquiry is about the regulatory route for a medical device you should email Devices.regulatory@mhra.gov.uk.
Further guidance
Medicines borderlines
Medical device borderlines
Guidance on standalone software (including apps)
Updates to this page
Published 21 June 2013Last updated 20 October 2020 + show all updates
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Added complaints information
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Update to MHRA’s Guidance Note 8: A guide to what is a medicinal product
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New PDF: Regulation 165 Notices issued from June 2016 – September 2019
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Updated attachment - Regulation 165 Notices issued from June 2016 – Feb 2019
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Updated attachment titled 'final determinations by MHRA on borderline products - March 2018'
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Added a link to new guidance on medical devices regulation in a no deal scenario.
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Uploaded a new version of the 'A guide to what is a medicinal product' document.
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Updated the Guide to what is a medicinal product (guidance note 8) to reflect amended appendices.
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Update medical devices document
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Updated final determinations for March 2018.
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Updated the document Urgent Notices issued by MHRA from June 2016
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Added the document Urgent Notices issued by MHRA from June 2016
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Alteration to number of product enquiries processed at a time by the borderline medicines team.
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Updated final determinations
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Updated list of final determinations
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Updated determinations
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Updated links
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new determinations
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Updated Borderlines between medical devices and medicinal products document and Borderlines between medical devices and other products (such as personal protective equipment, cosmetics and biocides document.
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First published.