Medicines and Medical Devices Act 2021 – Stakeholder survey
Page summary:
We invite feedback on the operation and impact of the human medicines and medical devices legislation as part of a statutory review required under the Medicines and Medical Devices Act 2021.
Change made:
First published.
Time updated:
9:10am, 21 July 2025
MHRA Performance Data
Page summary:
Performance data for MHRA key performance indicators (KPIs) and information on the expected timeline to complete a specific regulatory function.
Change made:
Published MHRA performance data for June 2025.
Time updated:
10:19am, 21 July 2025
Field Safety Notices: 7 to 11 July 2025
Page summary:
List of Field Safety Notices from 7 to 11 July 2025.
Change made:
First published.
Time updated:
11:02am, 21 July 2025
If you have any questions about the medical content in this email, contact MHRA on info@mhra.gov.uk
MHRA’s 2024–25 Annual Report and Accounts and Impact Report show progress on safety, innovation, and regulatory excellence
Page summary:
The Medicines and Healthcare products Regulatory Agency (MHRA) has published its 2024–25 Annual Report and Accounts, and accompanying Impact Report.
Change made:
First published.
Time updated:
4:41pm, 21 July 2025
Human Medicines Regulations 2012 Advisory Bodies Annual Report 2024
Page summary:
Annual Report of the Human Medicines Regulations 2012 Advisory Bodies – the Commission on Human Medicines (CHM) and the British Pharmacopoeia Commission.
Change made:
First published.
Time updated:
4:43pm, 21 July 2025
Medicines and Healthcare Products Regulatory Agency Annual Report and Accounts 2024 to 2025
Page summary:
MHRA annual report and accounts 2024 to 2025.
Change made:
First published.
Time updated:
4:44pm, 21 July 2025
Consultation on Medical Devices Regulations: Routes to market and in vitro diagnostic devices
Page summary:
The MHRA is inviting members of the public to provide their views on proposed changes to the regulatory framework for medical devices.
Change made:
Additional response published to international reliance, UKCA marking and in vitro diagnostic devices consultation proposal.
Time updated:
12:01am, 22 July 2025
Field Safety Notices: 14 to 18 July 2025
Page summary:
List of Field Safety Notices from 14 to 18 July 2025.
Change made:
First published.
Time updated:
11:39am, 22 July 2025
If you have any questions about the medical content in this email, contact MHRA on info@mhra.gov.uk
Trinity Biotech Premier Hb9210™ HbA1c Analyser: Risk of Positive Bias and Updates to Instructions for Use (IFU), including use as a diagnostic aid in diabetes mellitus (DSI/2025/003)
Page summary:
The MHRA has received reports describing a positive bias in HbA1c results delivered by the Trinity Biotech Premier Hb9210 HbA1c analyser, which has resulted in patients being incorrectly diagnosed as pre-diabetic or diabetic.
Change made:
First published.
Time updated:
2:21pm, 22 July 2025
If you have any questions about the medical content in this email, contact MHRA on info@mhra.gov.uk
MHRA announces proposals to improve access to world’s best medical devices for patients and to boost economic growth in Britain’s med tech sector
Page summary:
The MHRA has now published the government’s response to its public consultation on future routes to market for medical devices – designed to modernise regulation
Change made:
Added support received following this announcement
Time updated:
5:18pm, 22 July 2025
Summer ready: MHRA issues updated guidance on medicines and medical devices during holiday season
Page summary:
As the UK enters the heart of summer – with temperatures rising and families holidaying – the Medicines and Healthcare products Regulatory Agency (MHRA) is reinforcing essential safety advice for anyone using medicines or medical devices.
Change made:
First published.
Time updated:
11:21am, 23 July 2025
Regulation of medical devices in Northern Ireland
Page summary:
Information about how the MHRA regulates medical devices in Northern Ireland and what legislation applies to manufacturers and suppliers.
Change made:
Updated to reflect that 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.
Time updated:
12:42pm, 24 July 2025
Yellow Card centre launched in Northern Ireland to strengthen patient safety
Page summary:
A new regional centre to promote Yellow Card reporting has been launched in Belfast today.
Change made:
Updated to reflect that 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.
Time updated:
12:42pm, 24 July 2025
The Yellow Card scheme: guidance for healthcare professionals, patients and the public
Page summary:
Details of the system for reporting adverse drug reactions from medicines or adverse incidents with medical devices in the UK
Change made:
Updated to reflect that 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.
Time updated:
12:47pm, 24 July 2025
