AI Airlock: the regulatory sandbox for AIaMD
Page summary:
A proactive, collaborative, agile and the first of its kind approach to identifying and addressing the challenges faced by AI as a Medical Device (AIaMD).
Change made:
AI Airlock webinar recording link added.
Time updated:
4:31pm, 1 July 2025
Field Safety Notices: 23 to 27 June 2025
Page summary:
List of Field Safety Notices from 23 to 27 June 2025.
Change made:
First published.
Time updated:
2:15pm, 2 July 2025
If you have any questions about the medical content in this email, contact MHRA on info@mhra.gov.uk
Medical devices: Standardised format for the periodic safety update report
Page summary:
Information and recommendations for manufacturers on the preparation and presentation of a periodic safety update report (PSUR).
Change made:
First published.
Time updated:
9:22am, 3 July 2025
MHRA: policy for handling corporate conflicts of interest
Page summary:
Information about how we handle potential corporate conflicts of interest (COI) between different parts of the Agency.
Change made:
Addition of Annual conflict of interest compliance report – 2024/25
Time updated:
10:46am, 3 July 2025
Consultation on the International Council for Harmonisation (ICH) E21 Guideline on the Inclusion of Pregnant and Breast-feeding Individuals in Clinical Trials
Page summary:
The MHRA is consulting with UK stakeholders to gather feedback and comments on a new international guideline for the appropriate inclusion and/or retention of pregnant and/or breast-feeding individuals in clinical trials of medicines.
Change made:
First published.
Time updated:
12:51pm, 3 July 2025
Digital mental health technology: qualification and classification
Page summary:
Helping manufacturers define the characteristics of their devices and determine the appropriate regulatory qualification and classification.
Change made:
Added numbering for titles. Update to section ‘2. Development of this guidance’ to include details of stakeholder engagement. Update to section ‘6. Determining qualification as SaMD’ to include info on when DMHT does not qualify as SaMD. Update to section ‘6.2 Does the DMHT have sufficient functionality?’ to include background of concepts in EU and UK guidance. Wording for function 10. Update to ‘7. Accessories, multi-modular and inter-connected DMHTs’ for clarification. Update to ‘8.2. EU MDR classification rules for DMHTs’ due to published EU MDCG 2019-11 Rev 1 Guidance on qualification and classification of software in regulation (EU) 2017/745 – MDR and IVDR (2019).
Time updated:
1:51pm, 3 July 2025
Register medical devices to place on the market
Page summary:
How to register your medical devices with the MHRA for the markets in Great Britain and Northern Ireland.
Change made:
Increase to statutory fee effective 16 July 2025.
Time updated:
1:59pm, 3 July 2025
Medical devices: list of UK approved bodies
Page summary:
Details of the organisations that are currently approved to undertake conformity assessments on medical devices.
Change made:
Updated entry for TUV SUD BABT Unlimited (0168) to include:In-Vitro Diagnostic Medical Devices (designation expires on 2 July 2030)Under Part IV of the Medical Devices Regulation as they apply in Great Britain (SI 2002 NO 618, as amended) (UK MDR 2002)
Time updated:
12:37pm, 4 July 2025
Medical devices given exceptional use authorisations
Page summary:
List of manufacturers and their medical devices granted an exemption by MHRA. The list also includes manufacturers whose exemption expired or was cancelled.
Change made:
Extension issued to Greiner Bio-One GmbH (DEU/012/2024/003)
Time updated:
1:30pm, 4 July 2025
