The MHRA are the authorities responsible for medical device regulations throughout the United Kingdom.
In March 2020, the MHRA updated its guidance on distinguishing medicines and medical devices focusing on cases where the situation might be controversial.
The aim of this guidance is to ensure and assist all parties involved in making the correct decision in regards to borderline products.
In reference to the published guidance, the following products are determined as borderline products.
- Food products and supplements
- Medical devices
- Laboratory equipment
- Herbal products
MHRA further stressed that during cases where the borderline exists between medical products and medical devices.
The final call and decision should be based on the claims stated by the manufacturer with the product/device’s primary mode of action.
The MHRA would then be able to determine and recommend the appropriate regulatory framework to be applied.