UK MHRA updates advice on drug/device borderline issues
This article was originally published in Clinica
The UK’s Medicines and Healthcare products Regulatory Agency has issued an amended bulletin on Medical Devices and Medicinal Products. The 14-page bulletin, available online, provides 35 examples of products on the drug/device borderline and explanations of the regulatory criteria at play. With so many of the products, the classification depends on the mode of action.