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DBT seeks BIVDA member feedback on Rules of Origin

DBT colleagues are keen to have discussions with life sciences companies this month to better understand how current Rules of Origin (RoO) within certain UK trade agreements work. This engagement is separate from, though complementary to, other discussions you may be involved with related to the Department’s industrial and trade strategies. In particular, they’d like to discuss:  your sector’s current…
Ben Kemp
January 14, 2025
ConsultationsConsultations ArchiveMembership NewsMembership News Archive

Comments requested on UK SMI B 10: Investigation of faecal specimens for Clostridioides difficile

UKHSA requests your comments on the following document: UK SMI B 10: Investigation of faecal specimens for Clostridioidies difficile To take part in the consultation please go to the relevant page by clicking on the link below and navigate to the 'Open Consultation' accordion. Please send comments by 17th January 2025 using the consultation form provided on the website. The relevant…
Ben Kemp
January 7, 2025
Membership NewsMembership News Archive

Responsible AI: Women and Healthcare Conference Invite – Deadline 10 January 2025

Extra spaces have been made available for the upcoming Responsible AI: Women and Healthcare Conference taking place on Thursday 30th January 2025 at the Royal College of Obstetricians and Gynaecologists in London. However, you must sign-up before the deadline on 10th January. You can register here. This event brings together healthcare leaders, innovators and experts from across the fields of…
Ben Kemp
January 7, 2025
Membership NewsMembership News Archive

BIVDA respond to MHRA consultation on UK MDR amendments

BIVDA responded to the MHRA’s focused consultation on the proposed Pre-Market amendment to the UK Medical Device Regulation. The consultation, which closed on 5th January, focused on: International Reliance and associated pathways Proposal to remove the requirement for a physical UKCA mark Proposed route for UK Conformity Assessment Renewal of four pieces of assimilated EU law into UK Law which…
Ben Kemp
January 7, 2025
Membership NewsMembership News Archive

Reminder: Market Access and Procurement WP tomorrow – Thursday 16 January

A reminder to members to sign-up for the first working party of 2025: tomorrow's Market Access and Procurement Working Party on Thursday 16 January between 10:30 and 13:30. We look forward to welcoming David Lawson, Head of Medical Technology and Innovation at the Department of Health and Social Care, to provide an update on the MedTech Strategy. Jane Mills, Deputy…
Ben Kemp
January 7, 2025
Membership NewsMembership News Archive

Help inform the design of the multi-million pound Newborn Survival Prize

Challenge Works and LifeArc are conducting research to inform the design of a multi-million pound Newborn Survival Prize. There is an unmet clinical need for diagnostic tests and equipment to improve neonatal survival. The prize aims to incentivise the development and scale-up of diagnostic tools and/or equipment to reduce deaths from neonatal sepsis in low- and middle-income countries. Innovation in diagnostics for newborn sepsis…
Ben Kemp
January 7, 2025
Membership NewsMembership News ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA Medical Devices Regulatory Reform: Roadmap to implementation

The MHRA has published a revised roadmap, providing a further update on the intended timelines to implement the future medical device regulations. This new revision provides updates in four key areas, along with associated milestones and expected timelines for each. Please see here for more information.
Ben Kemp
December 18, 2024
Membership NewsMembership News Archive

UK Life Sciences Strategy

There are three key strategies currently being developed. Comprehensive Life Sciences Sector Plan: 10-Year Health Plan: NHS Innovation and Adoption Strategy: Aligning these strategies is critical with collaboration between government, industry, and the NHS is key. BIVDA has been invited to join the Life Sciences Sector Plan Advisory Group which considers the outputs from the defined Task & Finish Groups…
Ben Kemp
December 18, 2024
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