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MHRA: National AI Commission Call for Evidence

The MHRA have released a Call for Evidence regarding the regulation of AI in healthcare. This evidence will then inform the recommendations of the National Commission into the Regulation of AI in Healthcare. The Commission is a body which brings together experts from technology, healthcare, law, patient groups, the public, government, and the NHS. The MHRA is particularly keen to…
Ben Kemp
January 6, 2026
Membership NewsMembership News Archive

Application window for duty suspensions to UK Global Tariff

  The OLS would like to make members aware that applications are currently open for duty suspensions to the UK Global Tariff. They are also inviting stakeholders to submit views on extensions to existing suspensions. The application form and additional information can be accessed at this link. The deadline for both applications to new suspensions and submission of views on…
Ben Kemp
January 6, 2026
Membership NewsMembership News Archive

BIVDA & UL Emergo webinar: From Lab to Living Room: Applying Human Factors to Self Test IVDs

Make sure to register for BIVDA and Emergo by UL's webinar From Lab to Living Room: Applying Human Factors to Self Test IVDs. đź“… Tuesday 27th January 2026 ⏰ 2pm - 3pm This webinar will explore how human factors engineering principles can be applied to self‑test in vitro diagnostic devices (IVDs). Discussion will focus on regulatory expectations, practical approaches to…
Ben Kemp
January 6, 2026
Membership NewsMembership News Archive

Webinar: Implementing Pharmacogenetic POCT Devices Nationally

SBK are hosting a webinar on 'Implementing Pharmacogenetic POCT Devices Nationally' on Thu 29 Jan 2026 12:00-13:00 (1 CPD Hour). Join colleagues from across the UK as they explore the national rollout of pharmacogenetic POCT devices and their transformative potential to reduce inequity and deliver personalised care. Take one hour out of your busy day to hear from the National…
Ben Kemp
January 5, 2026
Membership NewsMembership News Archive

Member Spotlight: MDC Associates

MDC Associates (MDC) is delighted to be attending the upcoming BIVDA Regulatory Affairs Seminar, where the team will highlight its unique position as a U.S.-based CRO partner helping UK and European diagnostic innovators successfully navigate the complexities of the American regulatory landscape. For over three decades, MDC has been the trusted partner for companies developing in vitro diagnostics. With deep…
Ben Kemp
January 5, 2026
HighlightsHighlights Archive

New job opportunity: Contracts Manager at Sysmex

Sysmex are seeking a Contracts Manager to join their Commercial Support Services team. If you have the following attributes, you may consider applying here: Strong knowledge of tender and procurement regulations and commercial contract law Hands-on experience with NHS managed service contracts Understanding of UK diagnostics and healthcare market Excellent communication, influencing, and relationship-building skills Commercial awareness, attention to detail,…
Ben Kemp
January 5, 2026
Membership NewsMembership News Archive

NIHR UTI Diagnostic Innovation Workshop – 9th February 2026

We would like to draw members' attention to NIHR’s UTI Diagnostic Innovation Workshop on Monday, 09 February 2026, 10am to 4pm in Oxford. This workshop will offer an opportunity for innovators to network, connect and receive guidance from leading experts in urinary tract infection diagnosis and diagnostics evidence generation. It will also help to support your development in improving the…
Ben Kemp
January 5, 2026
HighlightsHighlights Archive

New qualifications in MedTech to tackle skills shortage

New Higher Technical Qualifications (HTQs) have been created by the Government to address skills shortages in the UK’s MedTech sector, with the aim of supporting workforce growth and improving NHS productivity. The qualifications can be delivered by colleges, private training providers and universities, and are designed to prepare learners for roles including technicians working with AI-enabled health technologies, such as…
Ben Kemp
January 5, 2026
ConsultationsConsultations ArchiveMembership NewsMembership News Archive

Changes to NICE regulations: cost-effectiveness threshold – members’ views needed

The UK government has proposed assuming direct control over the cost-effectiveness thresholds used by the National Institute for Health and Care Excellence (NICE), the body responsible for assessing the value of medicines and medical technologies. The proposal applies to both pharmaceuticals and medical devices. Under the proposal, responsibility for setting the threshold would move from NICE’s independent board to government…
Ben Kemp
January 5, 2026