GovWire

Please note that this guidance is in the process of being updated.

This guidance is specific to in vitro diagnostic devices placed on the market in Great Britain (England, Wales and Scotland). For guidance on the legislation applicable to in vitro diagnostic medical devices in Northern Ireland, please see our published guidance.

This document outlines the current controls on the sale and supply of in vitro diagnostic (IVD) medical devices and explains the main features of Part IV of the Medical Devices Regulations 2002?(SI 2002 No 618, as amended) (UK MDR 2002).

It should be read in conjunction with vigilance guidance for IVDs and advice for notified bodies on self-tests.

It covers:

• the scope of the UK MDR 2002
• the assessment process

• in-house manufacture