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Listed below are some of the more recent updates from MHRA
December 2025
- Updated guidance: Medical devices: conformity assessment and the UKCA mark Updated ‘Conformity assessment routes flowchart’.
- Updated guidance: Medical devices: get regulatory advice from the MHRA Updated attachment ‘Ask for Regulatory Advice’.
- New guidance (future regulations): In Vitro Diagnostics (IVD) Medical Device roadmap.
- Updated guidance: Clinical investigations for medical devices Update to ‘Assessment of CI applications’ wording.
November 2025
- Updated guidance: Clinical investigations for medical devices Updates to Flow Chart for GB Clinical Investigations to greater align with UK MDR, Updates/expansion of GB Flow Chart Accompanying Guidance, with examples, Added link to Northern Ireland performance studies submission guidance, Re-linking of CI biological safety guidance. New section ‘Pilot of a medical device clinical investigation fee waiver programme for micro and small sized enterprises’.
- Updated guidance: Register medical devices to place on the market Updated fees implementation and management guidance only, no change to content.
October 2025
- Updated guidance: Clinical investigations for medical devices Update #1. File ‘Clinical investigations of medical devices – guidance for manufacturers’ updated to reflect the following changes: Clarified EU MDR can be met for GB only studies (page 4). Updated point 5 on when application to MHRA is required and added links on where to find MHRA flow charts (page 6). Update #2 Included link to combined medicine and device trials guidance.
September 2025
- Updated guidance: Clinical investigations for medical devices Major update to guidance wording.
- Updated guidance: Medical devices: post-market surveillance requirements Added link to guidance for ‘Medical Devices: Standardised format for post market surveillance report (PMSR)’.
August 2025
- Guidance update: Clinical investigations for medical devices New flow chart and guidance documentation added for UK and Northern Ireland.
July 2025
- Guidance updated: Regulation of medical devices in Northern Ireland The Northern Ireland Adverse Incident Centre (NIAIC) incident and reporting function will be closing. From the 1st August 2025, healthcare professionals in Northern Ireland will report adverse incidents involving medical devices to the Yellow Card scheme in accordance with their organisations medical device policies and procedures.
- Fees revision: Register medical devices to place on the market Registration fee increase to £261 from 16 July 2025.
- Updated guidance: Clinical investigations for medical devices Added link to updated SME information (relating to fees).
- News: Government to align with European specifications on high risk in vitro diagnostic devices to reduce regulatory burden.
- Updated guidance: Digital mental health technology: qualification and classification Various updates including; Sections ‘6. Determining qualification as SaMD’, ‘6.2 Does the DMHT have sufficient functionality?’ ‘7. Accessories, multi-modular and inter-connected DMHTs’ for clarification, ‘8.2. EU MDR classification rules for DMHTs.
June 2025
- News: First major overhaul of medical device regulation comes into force across Great Britain New Post-Market Surveillance (PMS) regulations have taken effect across Great Britain, requiring medical device manufacturers to proactively monitor the safety and performance of their products once on the market.
- Guidance updated: Custom-made medical devices in Great Britain Updated to reflect the coming into force of The Medical Devices (Post-market Surveillance requirements) (Amendment) Regulations 2024.
- Guidance updated: Field safety notices: guidance for manufacturers Updated to reflect the coming into force of The Medical Devices (Post-market Surveillance requirements) (Amendment) Regulations 2024.
- Guidance updated: Medical devices: post-market surveillance requirements Updated to reflect the coming into force of The Medical Devices (Post-market Surveillance requirements) (Amendment) Regulations 2024.
- New guidance: Field safety notice (FSN): what it is and why it’s important A flyer to circulate to customers alongside a field safety notice covering what it is and why it’s important to take action.
- Guidance updated: Medical devices: periodic safety update report Updated PDF ‘Medical devices periodic safety update report (PSUR)’
- Guidance updated: Regulation of medical devices in Northern Ireland Update to reflect implementation of Article 10a Notification of interruption or discontinuation of the supply of a medical device.
- Guidance updated: MORE implementation Link added for ‘Documentation for implementation of data requirements under the new Post-Marketing Surveillance regulations’
- Guidance updated Borderline products: medical devices and other products Removal of paragraph 20. In-house manufacturing from the Borderlines page. This content is superseded on other published guidance pages.