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EU Parliament have approved the EU Commission’s proposal published on 23/1/24

The European Parliament have approved the European Commission’s (EC) proposal published on January 23, 2024. This proposal asks to amend the EU MDR (2017/745) and EU IVDR (2017/746) regarding the transitional extension for certain IVD devices, gradual roll out of EUDAMED and obligations in case of supply interruption. What does this mean? The additional time granted to manufacturers depends on…
Ben Kemp
April 29, 2024
Membership NewsMembership News Archive

Watch Springboard DBT webinar featuring Mark Oakes

Last week, the BIVDA Springboard Programme were pleased to welcome Mark Oakes, Head of Life Sciences at the Department for Business and Trade (DBT). Mark delivered a fantastic webinar to introduce DBT to our Springboard members and to help us explore all the ways we can work together to continue to build a strong UK life sciences industry. The webinar is available…
Ben Kemp
April 29, 2024
Membership NewsMembership News Archive

MIC drop launches HRCs

From 1st April, 14 new HealthTech Research Centres (HRCs) replaced the former MedTech and IVD Co-operatives hosted by the National Institute for Health and care Research (NIHR). Chief Executive Helen Dent presented to the NIHR team to maintain our ties into the new structure.  The HRCs are built to pull together healthcare professionals and industry. Helen set out how how…
Ben Kemp
April 24, 2024
Membership NewsMembership News Archive

MHRA designates new UK Approved Body for IVD devices and active implantable medical devices

The Medicines and Healthcare products Regulatory Agency have increased the capacity to process conformity assessments for active implantable medical devices and IVD devices with the addition of LNE-GMED UK Limited to their list of UK Approved Bodies, bringing the total number of UK Approved Bodies in the UK to 9. Approved bodies are organisations which the MHRA have designated to assess…
Ben Kemp
April 24, 2024
Membership NewsMembership News Archive

Springboard Webinar with the Department of Business and Trade (DBT)

This week, the BIVDA Springboard Programme were really pleased to welcome members of the Department of Business and Trade (DBT) who delivered a fantastic webinar called “The role of DBT and the Life Science Sector Team”. Mark Oakes, Head of Life Sciences at DBT, gave a presentation followed by an interactive Q&A session for attendees, where he talked us through…
Ben Kemp
April 24, 2024
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Media Monitoring: 18 – 24 April

Women’s health hubs The recently published 2024/25 operational planning guidance asks ICBs to “establish and develop at least one women’s health hub in every ICB by the end of December 2024 in line with the core specification. It sets the expectation that at least 75% of ICBs have a hub in place by July 2024 that meets minimum requirements. The…
Ben Kemp
April 23, 2024
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New £10.4M rare kidney disease research centre to pioneer new tests treatments

Thousands of people living with rare kidney disease will get access to improved diagnostics, treatments and potentially cures, thanks to the creation of a new research centre co-funded by Kidney Research UK and medical charity LifeArc. It will be led by experts from Alder Hey Children’s NHS Foundation Trust and the University of Liverpool. The LifeArc-Kidney Research UK Centre for Rare…
Ben Kemp
April 23, 2024
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Genomics in Scotland: Building our Future strategy released

The Scottish Government have released their 'Genomics in Scotland: Building our Future strategy', which establishes their commitment to the development of a robust and sustainable national genomic medicine service. The initial implementation plan will focus on the foundational and preparatory work needed, in collaboration with stakeholders across Scotland, to ensure that investment and partnership working is targeted to benefit those that…
Ben Kemp
April 23, 2024
Membership NewsMembership News Archive

Helen presents at Royal College of Pathologists Industry Leaders event

  Last Wednesday, Helen presented at the Royal College of Pathologists Industry Leaders event, on the theme of sector collaboration. Helen was clear the path to success is identifying common objectives, then working together to deliver them.  BIVDA play a key part in linking together all system actors and supporting the delivery process. Collaboration is fundamental to diagnostic pathways, through…
Ben Kemp
April 23, 2024