Please note this is an extract of the original bulletin.
How the MHRA makes decisions on when a product is a medical device (borderline products), and which risk class should apply to a medical device.
An additional section ‘Annex A – MHRA borderline determinations’ has been added to assist manufacturers to arrive at the appropriate classification for their products.
How to register your medical devices with the Medicines and Healthcare products Regulatory Agency (MHRA) for the markets in Great Britain and Northern Ireland
Updated ‘Manufacturer and Device and Product and Importer Attributes’ to July 2023.