Collection

Regulatory guidance for medical devices

Check the legal requirements you need to meet before you can place a medical device on the market and see how MHRA monitors compliance.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 18 December 2014
• Last updated: 31 March 2020 — See all updates

COVID-19 medical devices guidance

• Medical devices clinical investigations during the coronavirus (COVID-19) outbreak
  • 23 September 2020
  • Guidance
• Regulatory status of equipment being used to help prevent coronavirus (COVID-19)
  • 1 July 2023
  • Guidance
• Exemptions from Devices regulations during the coronavirus (COVID-19) outbreak
  • 17 December 2021
  • Guidance
• Specification for ventilators to be used in UK hospitals during the coronavirus (COVID-19) outbreak
  • 28 April 2020
  • Guidance

Documents

• Custom-made medical devices in Great Britain
  • 31 December 2020
  • Guidance
• Electronic instructions for use of medical devices: guidance on regulations
  • 14 March 2013
  • Guidance
• In vitro diagnostic medical devices: guidance on legislation
  • 17 July 2023
  • Guidance
• Medical devices: how to comply with the legal requirements in Great Britain
  • 31 December 2020
  • Guidance
• Medical devices: off-label use
  • 1 July 2023
  • Guidance
• Medical devices: software applications (apps)
  • 1 July 2023
  • Guidance
• Medical devices regulations: compliance and enforcement
  • 1 July 2023
  • Guidance
• Virtual manufacturing of medical devices
  • 1 July 2023
  • Guidance
• Notify the MHRA about a clinical investigation for a medical device
  • 21 September 2023
  • Guidance

Published 18 December 2014
Last updated 31 March 2020 + show all updates

1. 31 March 2020

   Added a new section on COVID-19 medical devices guidance

2. 29 March 2017

   Added a link to guidance for manufacturers who don’t design or manufacture devices but place their names on the product.

3. 11 January 2017

   Added a link to Medical devices: how to comply with the legal requirements guidance.

4. 16 May 2016

   Added new document on devices which incorporate an ancillary medicinal substance

5. 18 December 2014

   First published.