Latest guidance from MHRA
The Medicines and Healthcare products Regulatory Agency (MHRA) regulates IVD 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
December 2024
November 2024
- Page updated: Medical devices: UK approved bodies – Updated ‘UL International (UK) medical devices scope’.
- Open consultation: MHRA seeks views on routes to market for medical devices and in vitro diagnostics.
October 2024
- Press release: Statutory Instrument laid in Parliament sets out first steps in delivering Medical Device Regulatory Reform and strengthening patient safety.
- (New) Draft Statutory Instrument published: The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024.
September 2024
- Guidance updated: Clinical investigations – Updated the ‘In Vitro Diagnostic Medical Devices (IVDs)’ section and the section on ‘Amendments’ to reflect changes to the process.
June 2024
- (New) First published: Machine learning medical devices: transparency principles - Guidelines for communicating clear and relevant information about machine learning-enabled medical devices.
May 2024
- Press release: MHRA announces a proposed framework for international recognition of medical devices together with a Statement of policy intent.
- Press release: MHRA announces consultation on improved safety for high risk in vitro diagnostic devices.
- Guidance updated: Medical devices regulations: compliance and enforcement - ‘Medical devices: the regulations and how we enforce them’ updated to reflect changes to the legislation relating to MHRA’s investigatory and enforcement powers.
- Press release: MHRA launches AI Airlock to address challenges for regulating medical devices that use Artificial Intelligence.
- Press release: Update on pioneering initiative on regulation and evaluation of digital mental health technologies.
- Page updated: Medical devices: UK approved bodies – Updated details for LNE-GMED UK Limited.
April 2024
- Page updated: Medical devices: UK approved bodies – Added in-vitro medical devices and active implantable medical devices scope documents for LNE-GMED UK Limited.
- Guidance updated: Borderlines with medical devices and other products in Great Britain – Updated as of March 2024.
- Guidance updated: Assistive technology: definitions, examples and safe use - updated to provide clearer information as well as additional examples and guidance.
March 2024
- Page updated: Medical devices: UK approved bodies – Updated document for Intertek Medical Notified Body UK Ltd.
- Guidance updated: Regulation of devices in Northern Ireland - Updated to reflect the coming into force of The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 and to include information on MDCG guidance on the Health Institution Exemption.
February 2024
- Page updated: Regulating medical devices in the UK - The standard fee per application has changed to £240.
- Page updated: Medical devices: UK approved bodies – Updated scope documents for BSI Assurance UK Ltd.
January 2024
- age updates: Medical devices: UK approved bodies – Two new entries added; LNE-GMED UK Limited and Scarlet NB UK Ltd. Revised scope documents for; TUV SUD BABT, UL International (UK) Ltd and BSI Assurance UK Ltd.
- Guidance updated: Register medical devices to place on the market - Updated ‘Account Management Reference Guide’ & ‘Device Registration Reference Guide’, added a reminder of the legislation requirements for custom-made devices and a video ‘Registering a custom-made medical device’.
- Guidance updated: Implementation of the Future Regulations - guidance has been updated with a Roadmap towards the future regulatory framework for medical devices.
- (New) First publication: Roadmap towards the future regulatory framework for medical devices.
December 2023
- Page update: Register medical devices to place on the market - Clarification provided concerning fees and actions required to change legislation of a registered device.