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Ben Kemp

Membership NewsMembership News ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA announce new Post-Market Surveillance (PMS) regulations have taken effect

From the 16th June 2025, new legal requirements for monitoring the safety of medical devices take effect, as part of the MHRA's broader transformation of the UK’s medical device regulatory framework. The new Post-Market Surveillance (PMS) regulation is the first major overhaul of medical device regulation across Great Britain. The reform applies to all UKCA- and CE-marked devices placed on…
Ben Kemp
June 17, 2025
Membership NewsMembership News Archive

Make sure to register for the Near-Patient Testing Working Party — 3rd July

Join BIVDA's next Near Patient Testing Working Party meeting on Thursday 3rd July, 2pm - 4.30pm at our offices. We will be moving to a new, exciting format for our next NPT meeting to encourage discussions and conversations. Near Patient Testing - Actionable Steps towards the challenges of NPT Together we want to create actionable steps towards the challenges that we face…
Ben Kemp
June 17, 2025
Membership NewsMembership News Archive

BIVDA welcomes Viscera Technologies as new BIVDA members

BIVDA are pleased to welcome Viscera Technologies as new BIVDA members. Viscera Technologies brings laboratory-precision testing directly to patients through smartphone-powered lateral flow analysis. Their platform delivers quantitative results in minutes, not days, making professional-grade diagnostics accessible anywhere. They combine patented lateral flow technology with intelligent self-correcting algorithms—delivering laboratory precision anywhere, with any smartphone, enabling healthcare providers to make confident…
Ben Kemp
June 17, 2025
HighlightsHighlights Archive

Axel Heitmueller appointed Prime Minister’s Expert Adviser on Health

Downing Street has announced that Axel Heitmueller has been appointed as the Prime Minister’s Expert Adviser on Health. The Prime Minister’s Expert Adviser will advise ministers and drive forward the Government’s vision for health and social care. Members may know Axel from his time working as CEO of Imperial College Health Partners and Executive Director of Strategy at the Chelsea…
Ben Kemp
June 17, 2025
ConsultationsConsultations ArchiveMembership NewsMembership News Archive

Pathology Managed Services Policy Guidance Development – DHSC Call for Evidence launched

Many of you will be aware of the work undertaken by BIVDA and members over the last six months to make the case to DHSC for improving the approach to the procurement of Pathology Managed Services in the NHS. This has now culminated in a "call for evidence" launched last week by DHSC. This call for evidence will be the…
Ben Kemp
June 16, 2025
Membership NewsMembership News Archive

BIVDA’s message from NHS Confed Conference: “United we deliver, divided we fail”

BIVDA's own Beth Loudon attended the NHS Confed conference in Manchester last week and provided a summary of some of the key messages and themes. The event was well-attended with over 9,000 delegates registered, complete with multiple stages prepared for the conference's prestigious line-up of speakers. The main themes over the course of the conference were innovation, addressing health inequalities…
Ben Kemp
June 16, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Medical devices: post-market surveillance

Medical devices: post-market surveillance Page summary: Information for manufacturers of medical devices on post-market surveillance, reporting adverse incidents and field safety corrective actions to the MHRA. Change made: Link added for ‘Documentation for implementation of data requirements under the new Post-Marketing Surveillance regulations’ Time updated: 12:00pm, 9 June 2025
Ben Kemp
June 13, 2025
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