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Regulators mount up to deliver new action plan on growth

In their new action plan, the UK government candidly accepts the impact of over-regulation and sets out plans to reduce the burden on business. Citing countries such as Singapore and Australia who have continued to improve their regulatory systems, the plan acknowledges feedback from business and trade associations that regulation can be too complex and duplicative. There is a lack…
Paul Fisher
March 18, 2025
Membership NewsMembership News Archive

RHC counsel boldness on AI regulation

The government have set out their response to the recommendations made by the Regulatory Horizons Council (RHC) on the regulation of AI as a medical device. In a letter from Baroness Merron, the government has broadly welcomed the Regulatory Horizons Council (RHC) report on the regulation of Artificial Intelligence as a Medical Device (AIaMD) and provided a detailed response outlining…
Paul Fisher
March 18, 2025
Membership NewsMembership News Archive

Genomic data for over 37,000 children and parents from across the UK is now available to researchers worldwide

For the first time, genomic data for over 37,000 children and parents collected over multiple decades from across the UK is now available to researchers worldwide. High-resolution DNA sequencing creates a unique resource to explore the relationship between genetic and environmental factors in child health and development. The data release is led by the Wellcome Sanger Institute, Children of the…
Paul Fisher
March 13, 2025
Membership NewsMembership News Archive

Members win big at Bionow Awards

Congratulations to members Medicines Discovery Catapult and InvenireX for their wins at the 2024 Bionow Awards. MDC took home the Bionow Business Support Award for their work in turning drug discovery into commercial success, working with entrepreneurial scientists to make every move count with their approach to drug discovery driving game-changing breakthroughs and improving patients’ lives. Celebrating an exceptional individual within the first…
Paul Fisher
March 13, 2025
Membership NewsMembership News Archive

Impacted by DTAC or DCB0129? Let us know

BIVDA have been approached by a member concerned about both DTAC and DCB0129.  We are scoping the issue ahead of advocacy work. The Digital Technology Assessment Criteria for health and social care (DTAC) aim to give NHS staff and patients confidence that the digital health tools they use meet NHS clinical safety, data protection, technical security, interoperability and usability and…
Paul Fisher
March 13, 2025
Membership NewsMembership News Archive

DHSC plan to tackle rare diseases more effectively

The DHSC have launched their fourth action plan, setting out how they will implement the UK Rare Diseases Framework. Rare diseases, affecting fewer than one in 2,000 people, collectively impact over 3.5 million people in the UK. These conditions, while individually rare, are common when considered together. Examples include cystic fibrosis, Huntington’s disease, and muscular dystrophies, though many other rare…
Paul Fisher
March 13, 2025
Membership NewsMembership News Archive

MHRA pause plans to move to GMDN-based fees structure

MHRA announce pause in their proposal to move to GMDN-based fees structure. The MHRA have released their response to their October 2024 fees consultation. This proposed a new medical devices registration fee which would have significantly impacted the IVD industry, particularly SMEs, and was strongly opposed by BIVDA. The MHRA has decided to proceed with the wider fees uplift and…
Paul Fisher
March 13, 2025
Membership NewsMembership News Archive

BBC raise concerns over private at-home PSA testing

A BBC investigation has raised concerns over the accuracy and reliability of at-home prostate cancer tests, particularly rapid PSA (Prostate-Specific Antigen) tests. These tests detect elevated PSA levels in blood samples, which could indicate prostate issues, including cancer. However, the BBC's analysis of five different tests found significant inconsistencies: one test didn't work, three were negative, and one produced a…
Paul Fisher
March 13, 2025
Membership NewsMembership News Archive

COO at top of UKHSA

UKHSA appoint a new Chief Operating Officer and confirm Dyfed Alsop will cover as CEO after Jenny Harries Departure. Dyfed Alsop has been appointed as UKHSA’s new Chief Operating Officer and Deputy Chief Executive Officer, starting 1 May 2025. He has already begun working with UKHSA, attending meetings and building relationships across the agency, ahead of his formal start date…
Paul Fisher
March 13, 2025
Membership NewsMembership News Archive

Stephen Powis and other executives leave NHSE ahead of organisation’s merger with DHSC

England’s top doctor will leave his post in July, in the latest change at the top of NHS England. Professor Sir Stephen Powis, national medical director of NHS England, has announced that he will step down this summer, after over seven years in the role. Professor Powis notified outgoing NHSE Chief Executive Amanda Pritchard of his intention to stand down…
Paul Fisher
March 13, 2025
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