Medicines and Healthcare products Regulatory Agency Update (WC 5th January)

Medicines and Healthcare products Regulatory Agency

In Vitro Diagnostic roadmap

Page summary:
Sets out deliverables and timelines to support the development of safe In Vitro Diagnostic (IVD) medical devices.

Change made:
First published.

Time updated:
4:00pm, 15 December 2025

Implementation of medical devices future regime

Page summary:
Information on the new regulations for the post-market surveillance of medical devices which come into effect on 16 June 2025.

Change made:
Added link to ‘In Vitro Diagnostic (IVD) Medical Device roadmap’, which was published 15 December 2025.

Time updated:
4:00pm, 15 December 2025

Medical devices: get regulatory advice from the MHRA

Page summary:
How to apply for a regulatory advice meeting on medical devices and in vitro diagnostic devices.

Change made:
Changed to add a point on informal guidance under ‘the purpose of this guidance’ and updated attachment ‘Ask for Regulatory Advice’

Time updated:
4:39pm, 15 December 2025

MHRA welcomes Professor Jonathan Benger CBE as new CEO of NICE

Page summary:
Professor Benger’s leadership comes at a pivotal time as the MHRA and NICE deepen collaboration

Change made:
First published.

Time updated:
6:04pm, 15 December 2025

Medical devices: conformity assessment and the UKCA mark

Page summary:
How to conform with the legal requirements for placing medical devices on the market.

Change made:
Updated ‘Conformity assessment routes flowchart’.

Time updated:
11:38am, 16 December 2025

Professor Bola Owolabi CBE: Creating the Climate for Health Equity

Page summary:
Exploring the MHRA’s transformational impact on access, experience, and outcomes.

Change made:
First published.

Time updated:
3:40pm, 16 December 2025

Health Institution Exemption for general medical devices

Page summary:
Guidance for health institutions that manufacture general medical devices under the Health Institution Exemption (HIE).

Change made:
First published.

Time updated:
1:01pm, 17 December 2025

Medical devices: legal requirements for specific medical products

Page summary:
Information for manufacturers on the regulations that apply to prosthetic, orthotic and ophthalmic devices.

Change made:
Removed ‘Activities not covered by the UK MDR 2002’ paragraph from ‘Prosthetic and orthotic devices’ section.

Time updated:
1:02pm, 17 December 2025

MHRA updates guidance on the Health Institution Exemption to support safe use of medical devices

Page summary:
Updated MHRA guidance will help health institutions, such as NHS Trusts and Boards, safely design and make general medical devices for patients.

Change made:
First published.

Time updated:
1:27pm, 17 December 2025

MHRA strategy blog series

Page summary:
A series of articles from influential external voices about the challenges and opportunities ahead.

Change made:
Updated to include latest Strategy Blog post: Professor Bola Owolabi CBE: Creating the Climate for Health Equity

Time updated:
2:46pm, 17 December 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 Performance Data for November 2025.

Time updated:
5:04pm, 17 December 2025

Regulation of AI in Healthcare

Page summary:
The MHRA is seeking evidence on the regulation of AI in healthcare to inform the recommendations of the National Commission into the Regulation of AI in Healthcare.

Change made:
First published.

Time updated:
9:00am, 18 December 2025

MHRA seeks input on AI regulation at ‘pivotal moment’ for healthcare

Page summary:
National Commission is seeking evidence to shape regulation of AI in healthcare and support the UK’s ambition for a world-leading, AI-enabled NHS

Change made:
First published.

Time updated:
9:30am, 18 December 2025

MHRA Safety Roundup: December 2025

Page summary:
Summary of the latest safety advice for medicines and medical device users

Change made:
First published.

Time updated:
1:55pm, 18 December 2025

If you have any questions about the medical content in this email, contact MHRA on info@mhra.gov.uk

Medicines: get scientific advice from MHRA

Page summary:
A summary of the types of scientific advice available at the MHRA, the process for getting advice and the fees involved.

Change made:
Updated seasonal requests timeframes.

Time updated:
4:26pm, 18 December 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 BSI Assurance UK ltd designation details.

Time updated:
4:33pm, 18 December 2025