Latest guidance from MHRA

The Medicines and Healthcare products Regulatory Agency (MHRA) regulates medical devices in the UK.

Click the "Read more" link to see the latest guidance from MHRA published on www.gov.uk

Below is a summary of recent updates to the guidance published on www.gov.uk

October 2024

September 2024

August 2024

July 2024

June 2024

May 2024

April 2024

March 2024

February 2024

January 2024

December 2023

September 2023

June 2023

May 2023

April 2023

  • Page update: Medical devices: guidance for manufacturers on vigilance - Information and links to the MORE Submissions guidance and MORE production API guidance have been added.
  • Page update: Register medical devices to place on the market - Added Guidance on registration of medical devices with an expired or expiring CE certificate that is valid under EU Medical Devices Regulations.
  • Page update: Symptoms sometimes referred to as Breast Implant Illness - Information about a project to better understand how patients and the public perceive the risks has been included, as well as additional information about clinical stakeholders.
  • Page update: Regulating medical devices in the UK - This guidance was updated primarily to reflect an intended extension to acceptance of CE marked medical devices on the Great Britain market beyond 30 June 2023. This guidance has been updated with changes to ‘Summary of key requirements for placing a device on the Great Britain market’, ‘Registrations in Great Britain’, ‘UKCA marking’, ‘CE marking and Notified Bodies’, ‘Labelling requirements’ and ‘Regulation of medical devices in Northern Ireland’ Reference Guides.
  • Page update: MHRA fees - Updated MHRA fees for 2023 – 2024. Added links: The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023 & The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023.

March 2023

  • Page update: Export medical devices - Updated ‘Certificates of Free Sale for Medical Devices’ PDF.
  • Page update: Register medical devices to place on the market - Updates to the Review Registration, Making Changes to your registration and Public Register of Manufacturers sections. Updated Account Management and Device Registration Reference Guides.
  • Page update: MHRA fees - Added link to application form to ‘apply for Small and Medium Company status’.

January 2023

December 2022

November 2022

October 2022

September 2022

July 2022

June 2022

May 2022

March 2022

January 2022

  • Guidance update: Regulating medical devices in the UK - Updated to reflect changes to medical device regulatory requirements that took effect on 1 January 2022 – suspension of registrations of Authorised Representatives and of non-UK manufacturers without a UK Responsible Person.
  • Guidance update: Register medical devices to place on the market  - Updated to reflect changes to medical device registration requirements that took effect on 1 January 2022 – non-UK manufacturers require a UK Responsible Person for registering devices placed on the Great Britain market. Authorised Representatives, including those based in Northern Ireland, can no longer register devices on a non-UK manufacturer’s behalf for the Great Britain market.
  • Guidance update: Notify the MHRA about a clinical investigation for a medical device - MHRA and HRA coordinated assessment pathway added to guidance.

November 2021

October 2021

September 2021

August 2021

July 2021

June 2021

May 2021

April 2021

March 2021

February 2021

January 2021