Medicines and Healthcare products Regulatory Agency (MHRA) Regulating medical devices in the UK:
Overview:
The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating the UK medical devices market.
This guidance provides information on the UK system, including for:
- getting your device certified
- conformity marking your device
- registering your device with the MHRA
This guidance is divided into sections on the different rules that apply in Great Britain, Northern Ireland and the EU. Great Britain is England, Wales and Scotland.
Under the Northern Ireland Protocol, different rules apply in Northern Ireland to those in Great Britain. For more information on the regulatory system for medical devices in Northern Ireland, please see Regulation of medical devices in Northern Ireland below.
In this guidance, “medical device” includes in vitro diagnostic medical devices and active implantable medical devices.
This guidance only applies to medical devices and does not cover other CE or UKCA marked products, which are subject to separate guidance.
This information is meant for guidance only. You should consider whether you need separate professional advice before making specific preparations. Speak to your solicitor or trade association if you are unsure which regulatory framework applies to your goods.
Click on the headings below for complete details
Table of Contents
Legislation that applies in Great Britain
Requirements for those manufacturing and supplying devices in Great Britain
Registrations in Great Britain
UKCA mark and Conformity Assessment Bodies
CE marking and Notified Bodies
Labelling requirements and Post-market surveillance and vigilance
Who regulates medical devices in the UK?
