EU UDI: what lies beneath for device manufacturers?
This article was originally published in Clinica
Executive Summary
The EU is some way behind the US in getting to grips with UDI needs for devices, but the resulting increased transparency and visibility will bring new levels of trust and confidence to the market.
You may also be interested in...
UK MHRA Updates Assistive Tech And Borderline Regulations
Device classification themes were uppermost in April for the UK regulator, which issued key guidance in two areas prone to complexities. It also contributed to the MedTech Directorate’s one-year progress report.
Helping Organizations Deliver On KPIs And Giving Staff A Voice
ImproveWell has won awards for its software technology that allows health care staff at the sharp end of patient care to report on problems as they happen. The outcome is a real-time learning process that contributes to improved operational efficiencies for health systems, says In Vivo Rising Leader Lara Mott.
UK Medtech Strategy Sets Out Schedule Of Milestones To FY 2026
Fourteen months on from the release of its inaugural medtech strategy, the UK MedTech Directorate has laid firm foundations and reports progress on initiatives aimed at improving technology adoption. A schedule of ambitious future timelines has also been published.