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European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Advice on SARS-CoV-2 on request from the Medical Device Coordination Group (29 January 2025)

At the request of EU MDCG, EMA Expert Scientific Committee was asked to provide a scientific opinion on the current status of SAR-CoV-19, so they can review the current classification as an EU Class D device. Please find below link to the Scientific opinion and the update on the MDCG webpage. Future updates of the MDCG Guidance on classification will…
Ben Kemp
February 7, 2025
Membership NewsMembership News Archive

BIVDA Board Elections

Interested in steering BIVDA’s activities and influencing the diagnostics sector at the strategic level? BIVDA have some upcoming vacancies on our board. BIVDA’s board members play a vital role in guiding the secretariat’s activities, setting our strategic direction and providing governance.  Supported by our incoming chair, Richard Hames, and our President, Angela Douglas MBE, this is an opportunity to play a…
Ben Kemp
February 4, 2025
HighlightsHighlights Archive

NHS mandate and operational planning guidance and priorities 25/26 published

In a busy week for NHS policy, the government’s have published their mandate for the health service, and operational planning guidance and priorities for the coming twelve months. NHS Mandate Announcing the mandate, Health Secretary Wes Streeting doubled-down on his assertion that the health service was broken, not beaten. Mr Streeting reiterated that extra money was not the solution, stating…
Ben Kemp
February 4, 2025
HighlightsHighlights Archive

Chancellor makes growth speech at BIVDA member facility

Last week, Chancellor Rachel Reeves delivered a significant speech yesterday, outlining her vision for driving growth in the UK economy at BIVDA member Siemens Healthineers' facility in Eynsham. This is a strong endorsement of the life sciences industry, which the Chancellor rightly hailed as world-leading in her address, and has been identified by the government as a key growth sector.…
Ben Kemp
February 4, 2025
Membership NewsMembership News Archive

Introducing the new Social Value TOM System™ webinar recording available

Members may wish to access the webinar recording of the first session of the 'Introducing the new Social Value TOM System™' series, which can be accessed here. This webinar provides a first look at the new Social Value TOM System, including updates to themes, evidence, guidelines, and an expanded scope. You will also discover the Open Access TOM System, a free…
Ben Kemp
February 4, 2025