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
  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.

COVID-19 medical devices guidance

• Regulatory status of equipment being used to help prevent coronavirus (COVID-19)
  • 1 July 2023
  • 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
  • 20 July 2026
  • Guidance
• Electronic instructions for medical devices
  • 14 March 2013
  • Guidance
• In vitro diagnostic medical devices: guidance on legislation
  • 15 January 2025
  • Guidance
• Medical devices: how to comply with legal requirements in Great Britain
  • 15 January 2025
  • Guidance
• Off-label use of medical devices
  • 1 July 2023
  • Guidance
• Medical devices: software applications
  • 1 July 2023
  • Guidance
• Medical devices: compliance and enforcement of the regulations
  • 17 May 2024
  • Guidance
• Virtual manufacturing of medical devices
  • 1 July 2023
  • Guidance
• Clinical investigations for medical devices
  • 12 August 2026
  • Guidance