Guidance on Class 1 Medical Devices

This guidance applies to manufacturers of Class I medical devices, including accessories but excluding devices intended for clinical investigation and custom-made devices.

This guidance is divided into sections on the different rules that apply in Great Britain (England, Wales and Scotland) and Northern Ireland.

For Northern Ireland, different rules apply to those in Great Britain. For more information on the regulatory system for medical devices in Northern Ireland, please see the section on Class I devices in Northern Ireland below.

CE marked devices will continue to be accepted on the Great Britain market until 30 June 2023. You will be able to self-certify your Class I medical device for the CE mark, and place your device on the Great Britain market. You will not require an Authorised Representative if you are solely placing your Class I device on the Great Britain market. If you are self-certifying your Class I medical device for the CE mark, you will need to meet the requirements of the Medical Devices Regulation (2017/745) from 26 May 2021.