Thought leadership
MHRA confirms international reliance routes, IVD changes, UDI approach and plan for indefinite CE recognition for medical devices
24 July 2025
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Thought leadership
Practical impacts in UK health sector of government policy to ensure regulation promotes growth
3 April 2025
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Thought leadership
MHRA launches Real-World Evidence programme to support approvals and HTAs
15 January 2025
Thought leadership
The Innovation Ecosystem report: a roadmap for the adoption and spread of innovation in the NHS
17 December 2024
Thought leadership
MHRA consultation on medical device reforms: international reliance, removing UKCA mark and aligning IVDs classification with EU
18 November 2024
Thought leadership
MHRA to relaunch the Innovative Licensing and Access Pathway (ILAP) for medicines
7 November 2024
Thought leadership
DHSC confirms further changes to Statutory Scheme for pricing of branded medicines
5 November 2024
Thought leadership
New Post-Market Surveillance SI published to align UK with EU, subject to key differences for medical device manufacturers
24 October 2024
Thought leadership
Pioneering regulation enables manufacture of modular and point of care medicines in the UK
24 October 2024
Thought leadership
New Regulatory Innovation Office aims to speed up approvals for novel technologies
14 October 2024
Thought leadership
New MHRA data strategy to harness Real World Evidence and AI to drive medical product innovation
25 September 2024
Thought leadership
MHRA update on AI Airlock, the regulatory sandbox for AI Medical Devices
31 July 2024
Thought leadership
MHRA, FDA and Health Canada publish transparency guidance for machine learning medical devices
18 June 2024
Thought leadership
MedTech strategy update and new definition of "innovative" - key points for medical device manufacturers and developers
24 April 2024
Thought leadership
What does the HealthTech market need to know about AI law and regulation?
15 April 2024
Thought leadership
Public Accounts Committee challenges NHS Supply Chain on procurement savings
15 April 2024
Thought leadership
Spring Budget 2024 – Health Tech and Life Sciences funding announced
7 March 2024
Thought leadership
Health Tech Series: Government asks MHRA to publish strategy for AI regulation in healthcare
20 February 2024
Thought leadership
Health Tech Series: MHRA reveals timeline for new medical device regulations
18 January 2024
Thought leadership
New EU strategy for developing and using AI in health and life sciences
8 January 2024
Thought leadership
DHSC confirms new statutory scheme for pricing of branded medicines
15 December 2023
Thought leadership
Government continue AI healthcare push with new £100m fund and regulatory sandbox
1 November 2023
Thought leadership
Consultation on mandatory disclosure of industry payments to the healthcare sector
13 September 2023
Thought leadership
New MHRA guidance on international recognition route for UK medicines approvals
11 September 2023
Thought leadership
MHRA designates three new Approved Bodies to certify medical devices in the UK
4 September 2023
Thought leadership
MHRA announces new recognition routes for medicines with approvals in other countries
13 June 2023
Thought leadership
MHRA publishes new adverse incidents guidance for Software as a Medical Device
22 May 2023
Thought leadership
Major reform of clinical trials regulation in the UK – what are the key changes?
27 March 2023
Thought leadership
New service to help AI and Health Tech providers understand regulatory landscape in UK
17 March 2023
Thought leadership
Life Sciences Budget 2023 – funding for AI and regulatory reform of medicines and medical devices
16 March 2023
Thought leadership
UK Government signals further commitment to reform of medical device regulation aimed at growing the life sciences sector
31 January 2023
Thought leadership
MHRA wins funding for digital, data and AI innovation linked to clinical trials and software as medical device
21 December 2022
Thought leadership
MHRA reveals roadmap for regulatory reform of Software and AI as a medical device
24 October 2022
