Saturday, 23 January 2016

Borderlines between medical devices and medicinal products


What is the difference between a medical device and a medicinal product? The definitions are often blurred.

To help to interpret this, the U.K. MHRA have a document that sets out, in broad terms, the regulation of specific products and distinguishes those which are regulated as medical devices and those which are regulated as medicinal products, particularly where the regulation may be on the borderline between the two sets of regulations.

Whilst there are other ‘borderlines’ with medical devices (for example with cosmetics, personal protective equipment, biocides etc) this document relates specifically to the differentiation between medical devices and medicinal products.

To access the document, see: MHRA.



 Posted by Dr. Tim Sandle