A number of our USA clients have come to us for help in Europe when developing a medicinal product or medical device (or combination of the two) that is classified in one way in the USA, but another way in Europe. It is sometimes tricky to decide how to classify certain healthcare products.
The MHRA recently issued updated guidance on this matter. This guidance is helpful for all of the EEA, as it relates to EU legislation. Remember, although the UK has left the European Union, they are still in the transition period and so operating under EU legislation.
Contact us via our website or email us for more information on how we can help. We have summarised some of the details below.
What is a Borderline Product?
Many different types of product fall in to the borderline category including:
• medical devices
• food supplements
• herbal products
• machinery/laboratory equipment
In addition, there is also a borderline between medicinal devices and medical products. The mode of action and product claims will determine which regulatory regime will apply.
Article 1(2) of the European Directive 2001/83/EC3 establishes the following definition of a medicinal product:
• 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
National Competent Authorities (NCAs) within the EU decide on a case-by-case basis whether the claims that are made or the active substance(s) present would mean that the product is regarded to be a medicinal product.