United Kingdom
Joint Singapore-UK plan underlines direction of travel for MHRA after its embracing of international reliance (IR). Australia’s TGA has also broken new ground by recognizing the UKCA mark.
Roadmap version 1.0 is a living document, not a legislative instrument, that will be updated and tweaked for timings as necessary.
Digital technology and AI have pushed healthcare delivery to a transformational turning point, but market access, budget constraints and scaling adoption of innovation remain the eternal challenges for healthtech manufacturers.
The MHRA’s premarket statutory instrument for Great Britain should to be laid before UK parliament in Q2 and be in force by year end, in an ideal world. There are concerns that the new statutory instrument must align with imminent EU MDR changes.
The UK Medicines and Healthcare products Regulatory Agency said its RegulatoryConnect program “no longer offers value for money for UK taxpayers” and will be closed just 19 months after its April 2024 launch.
The prosthetics market is evolving due to an increase in amputees from war and disease. Unhindr has developed a novel prostetic liner that can reduce the risk of further injury, while Esper is crafting advanced hand implants for Ukraine's front-line soldiers.
The first-of-its-kind sandbox for insights on how to regulate artificial intelligence in healthcare has accepted seven more AI innovators onto its learning program.
Market and regulatory support for 117 new and 91 existing devices under 2024-25 technology funding program run by UK innovation agency CPI benefits 141 SMEs – but demand for regulatory support outstrips supply.
June Raine was a “hard act to follow” at MHRA, but new chief executive Lawrence Tallon is looking to the future in setting out a vision for the UK regulator.
Evidence-based testing in real clinical settings and diagnostics tailored to community needs are crucial adoption success factors for new IVDs, Michael Wright, joint medical director at Newcastle Hospitals NHS Foundation Trust, told Medtech Insight at a regional UK meeting.
At LSX World Congress USA, medtech executives shared lessons on global expansion, from regulatory pitfalls to cultural nuances and funding gaps. Their message: Prepare early, secure capital, and choose partners wisely.
Sava Technologies has developed a CGM that uses microneedles to accurately measure glucose levels for up to 10 days without finger-prick calibration. The company raised £14.2m in Series A funding to establish in-house manufacturing for faster production.
MHRA changes how it will charge device companies for post-market surveillance work based on GMDN codes registered to the relief of SMEs.
Salient's inflammatory bowel disease test, built on the start-up’s Signal platform, is planned to launch in March 2026. The company leverages rich data from existing wellness tests to develop signatures, focusing on conditions that are often misdiagnosed and disproportionately affect women.
The UK government expects that its new nation-wide network will enable companies to set up clinical trials more quickly and expand access to diverse patient populations across the National Health Service.
The ceramic device, designed to reduce complications, will be exclusively distributed by Zimmer Biomet and initially available in 30 hospitals, with broader European access expected by 2026.
A government-backed program is working on improving the ability to run dementia clinical trials in the UK, and access to trials for participants.
The UK device regulator wants to align health institution device exemptions with its evolving policy of agile regulation of medtech in the British market. It asks stakeholders to complete a survey by Sept. 15.
Daye is launching an at-home reproductive hormone testing service in the UK, utilizing a painless upper arm blood collection method. The product’s UKAS lab accreditation helps build credibility with healthcare providers.
HistoSonics’ CEO Michael Blue describes the deal as a win-win for all stakeholders and plans to use the money to expand clinical indications, as well as the global reach, for its Edison system.