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MHRA investigation leads to convictions in counterfeit baby feeding devices case
Medicina supplied devices bearing false CE markings to healthcare providers including National Health Service (NHS) Trusts across the UK.
NHS Confed 2026: what drives successful AI implementation in the NHS?
Coherent leadership and careful implementation of AI in the NHS were key talking points at the 2026 NHS Confed Expo.
FDA and MHRA forge new regulatory collaboration initiative
The new initiative is intended to improve the global oversight of medical devices, AI, and innovative medicines and to streamline knowledge sharing efforts.
Industry calls for substantial reform to UK’s AI regulation in healthcare
Respondents to the MHRA’s survey highlighted that new AI healthcare regulation must do more to address privacy, safety, and transparency.
Women’s health apps: governance and transparency key to success as opportunities bloom
Experts say that prioritising data privacy and governance, while focusing on proactive regulatory interactions, can help developers make a success of their digital health apps.
Fast, Expert, Open: Lawrence Tallon’s vision for the MHRA
Lawrence Tallon on priorities as MHRA CEO, the evolution of UK medical device regulation and the agency’s future leadership.
Podcast: MHRA CEO Lawrence Tallon on the future of medical device regulation in the UK
Lawrence Tallon, CEO of the MHRA, discusses the agency's initiatives to advance the UK's regulatory protocols for medical devices.
MHRA secures $4.8m to expand AI medical device programme
AI Airlock is jointly run by the MHRA, DHSC, NHS AI Team, and Team AB, the consortium of UK Approved Bodies.
Neurovalens receives EU MDR compliance for sleep insomnia device
Achieving MDR compliance shows Modius Sleep meets safety, clinical, and quality standards required for entry into the EU market.
LifeVac receives FDA De Novo classification for anti-choking device
LifeVac is approved for use as a single-use, non-powered, non-invasive airway clearance device.
Daiichi and GAIA join forces to commercialise digital cardiovascular therapy
Pharma companies are increasingly combining the strengths of pharmaceutical and digital health interventions to improve outcomes.
Medical device testing in UK rises amid global competitiveness push
This increase in activity comes as the UK looks to enhance its standing in the medtech sector as global competition mounts.
MHRA launches consultation on UK’s long-term approach to CE-marked medical devices
One of the key proposals the MHRA seeks feedback on is the ‘indefinite recognition’ of EU CE-marked medical devices in the UK.
UK government champions healthtech through new NHS access programme
The National Healthtech Access Programme aims to improve accessibility to healthtech products across the NHS.
MHRA outlines upcoming IVD submission shift for clinical trials
From 28 April, IVDs used clinical trials will be subject to an upfront assessment by the MHRA as part of a Clinical Trial of an Investigational Medicinal Product submission.
New MHRA resources prompt clarity on use of digital mental health tools
The MHRA’s new resources are intended to help individuals make better-informed decisions about the digital mental health support tools they use.
The importance of real-world evidence in transforming healthcare decision-making
Real-world evidence (RWE) empowers payers and providers to make more informed, cost-effective treatment and coverage decisions by addressing key knowledge gaps.
UK reforms highlight the case for digital submissions in medical device regulation
Diogo Geraldes, director of regulatory strategy, Europe at Veeva MedTech, discusses the potential of digital submissions to benefit manufacturers, regulators, and patients.
Wellcome backs MHRA and NICE’s digital mental health tech push with £2m funding
The funding from the Wellcome Trust will aid the entities in continuing their work on developing safety protocols around digital mental health technologies.
The transatlantic medtech investment gap: why does it exist and can it be plugged?
Ivor Campbell, CEO of medtech recruitment consultancy Snedden Campbell, reflects on what companies in the UK and Europe can do to compete for investment against the US.