UK – Guidance : Register as a manufacturer to sell medical devices

Register a manufacturer or authorised representative (agent) for a manufacturer, to sell medical devices, including in vitro diagnostic (IVD) medical devices.

If you place certain medical devices on the EU market you or your designated authorised representative must register with the competent authority (national health regulator) in the EU state where you have an office or place of business. In the UK, Medicines and Healthcare products Regulatory Agency (MHRA) is the competent authority for the registration of medical devices. MHRA will only register manufacturers or authorised representatives that have a place of business in the UK…