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BIVDA Market Audit shows recovery of UK IVD market

The BIVDA Market Audit Report for Q1 and Q2 2024 has been published for companies participating in the UK. BIVDA's Market Audit shows growth in the UK IVD market, after accounting for the reduction in COVID-19 testing. There is significant recovery in the core laboratory testing market with the exception of infectious diseases. The total IVD market is assessed at…
Ben Kemp
September 10, 2024
Membership NewsMembership News Archive

Lord Darzi Review holds expert group meeting following consultation

Lord Darzi’s Review into NHS performance recently held a meeting with experts to report on their assessment of submissions to the review.  BIVDA’s Helen Dent attended to represent the IVD industry. There were over 300 submissions from the Life Science sector. These contained few surprises – there is wide awareness of the NHS’s performance and challenges.  Quality of care is…
Ben Kemp
September 4, 2024
Membership NewsMembership News Archive

BIVDA Parliamentary Reception – 30 October 2024

In eight weeks, BIVDA host our 2024 Parliamentary Reception and bring together one hundred of the most influential figures in the IVD industry. Speakers include former Health Minister Lord Darzi, Director of the Office of Life Sciences Roz Campion, and MD of NHS Pathology London NW Saghar Missaghian-Cully. With attendees including NHSE Chief Commercial Officer Jacqui Rock, Deputy Chief Scientific…
Ben Kemp
September 4, 2024
Membership NewsMembership News Archive

Deadline to submit abstracts for the UKHSA Conference 2025 extended

The deadline to submit abstracts for the UKHSA Conference 2025 has been extended to Tuesday 24 September. The conference itself will take place in Manchester between 25 - 26 September in Manchester. Abstracts are invited for both oral and ePoster presentation and submissions that showcase the best in science, innovation and policy from colleagues within and beyond UKHSA across the…
Ben Kemp
September 3, 2024
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Book tickets for the NICE Conference 2025

NICE's 2025 conference will take place on 27 March 2025 and will celebrate 25 years of independence, transparency and rigour. The conference will explore NICE's continued commitment to deliver relevant, timely and impactful guidance. The event brings together frontline staff and leaders from health and care together with the life sciences, healthtech and digital sectors, to explore how NICE continues…
Ben Kemp
September 3, 2024
Membership NewsMembership News Archive

NHS Innovation Accelerator applications open

Applications for the NHS Innovation Accelerator (NIA) 2025 cohort are now open. This is your chance to join a transformative programme that is dedicated to scaling high-impact innovations and driving meaningful change in healthcare. Why Apply? National Impact: Engage in a groundbreaking programme with the potential to transform healthcare across the nation. Your innovation will have the opportunity to reach a broader…
Ben Kemp
September 3, 2024
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WHO urges rapid access to mpox diagnostic tests

With regard to the recent spread of clade I Mpox declared by the World Health Organization (WHO) a health emergency of international concern on 14 August. Please find below a recent communication from WHO, calling for a coordinated international response to the virus outbreak: Last week, the WHO asked manufacturers of mpox in vitro diagnostics (IVDs) to submit an expression of…
Ben Kemp
September 3, 2024
MedTech Europe Updates Regulatory Affairs NewsletterMembership NewsMembership News ArchiveRegulatory Affairs Newsletter

Feedback on EU RoHS exemption pack utilisation

BIVDA and MedTech Europe are gathering information on the EU RoHS (including Northern Ireland), exemption pack renewal for Lead and Mercury in product type 8 – medical devices include those specifically for IVDs. If you rely on the exemption packs for RoHS compliance to place products on the EU and/or Northern Ireland markets, then please let BIVDA know. MedTech Europe…
Ben Kemp
September 3, 2024
Membership NewsMembership News Archive

Access BIVDA Webinar on “Counterfeits and Copyright”

Last week, BIVDA were excited to host our "Counterfeits and Copyright" webinar, where we welcomed the Rachel Jones from SnapDragon Monitoring to talk to members of our Springboard Programme. Rachel provided hints and tips around online monitoring for illicit material and ensuring its quick and efficient removal using intellectual property rather than cumbersome legal processes. Online brand protection is now…
Ben Kemp
September 3, 2024
Membership NewsMembership News ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA launch statutory fees consultation

The MHRA last week launched a consultation on statutory fees proposals for April 2025 until March 2027. Unsurprisingly, the trajectory is upwards - in some cases (such as clinical trials) significantly. BIVDA’s Head of Policy and Programmes, Paul Fisher noted, "These proposed increases will disproportionately impact SMEs - the sector that the government and NHS recognise as a key part…
Ben Kemp
September 3, 2024