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Ben Kemp

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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
HighlightsHighlights Archive

UK to join CPTPP by end of 2024

The UK has secured the sixth and final ratification required to trigger accession to the Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP) before the end of this year. CPTPP is a free trade area spanning five continents and almost 600 million people once the UK joins. Following Peru’s ratification of our deal to join the bloc, the agreement will…
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
Membership NewsMembership News Archive

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
HighlightsHighlights Archive

Government to roll-out workplace health checks to over 130,000 people

Over the next six months, more than 130,000 people in England will be invited to participate in free workplace health screenings as part of a new initiative aimed at preventing heart disease. Starting in September, employees across various industries, including construction and hospitality, will have access to quick assessments designed to evaluate their risk of developing cardiovascular disease (CVD), a…
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
Membership NewsMembership News Archive

UKHSA issue request for information regarding available options to test for Mpox from POCT suppliers

UKHSA seek to gather comprehensive information regarding the available options to test for Mpox from the Point of Care Testing suppliers awarded on the new Laboratory Diagnostics, Point of Care Testing & Pathology Managed Services (OJEU REF - 2023/S 000-001309) NHS Supply Chain framework. To aid them in their efforts, please provide detailed insights by responding to this Request For…
Ben Kemp
August 29, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUpcoming Events Regulatory Affairs NewsletterUpcoming Events Regulatory Affairs Newsletter Archive

IFCC Webinar: “Minimum quality specifications based on the state of art” 4 September, 2024

This webinar comprises of three following presentations of 20 min each followed by 20 min of panel discussion at the end. Chair: Dr. Raul Girardi Talk 1- "State of the art" - Dr. Jorge Morancho Zaragoza Talk 2- "Algorithm for obtaining consensual minimum quality specifications" - Dr. Angel Manuel Salas García Talk 3- "State of the Art Charts" - Dr. Enrique Prada de Medio…
Ben Kemp
August 28, 2024
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