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Ben Kemp

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MHRA AI Airlock Webinar – 19th June

The MHRA will hold a webinar on 19th June at 10:00 - 11:30 to provide an update on the AI Airlock pilot programme that ran from April 2024 through to March 2025, including a summary of the pilot projects, early insights into recommendations and lessons learnt. You will also hear about the second phase of the programme including the key…
Ben Kemp
June 2, 2025
Events DiaryMembership NewsMembership News Archive

The Future of Diagnostics in the NHS – Masterclass featuring BIVDA’s Angela Douglas and Beth Loudon

BIVDA's President, Angela Douglas, and Head of Market Access, Beth Loudon, will feature in the upcoming Life Science Access Academy masterclass titled The Future of Diagnostics in the NHS on 17th June at 13:00 - 14:00. Joined by Scott McKenzie, they will examine the changing landscape of diagnostics, including new NHS commissioning models, policy shifts, and emerging innovations shaping the…
Ben Kemp
June 2, 2025
HighlightsHighlights Archive

NHS first in world to roll out ‘revolutionary’ blood test for cancer patients

NHS England are set to roll-out a revolutionary world-first liquid biopsy test for tens of thousands of lung and breast cancer patients. The test can help to accelerate access to targeted therapy for lung cancer patients by up to two weeks and potentially spare some patients from invasive procedures and treatments such as chemotherapy. This new ‘blood test-first’ approach for…
Ben Kemp
June 2, 2025
Membership NewsMembership News ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

2 weeks to ensure compliance with the new UK Post Market Surveillance Regulations

Members have just over 2 weeks to ensure compliance with the new UK Post Market Surveillance Regulations. This date sees a significant update to the UK Medical Device Regulation 2002 for IVDs and medical devices. Stuart Angell, Chair of BIVDA's Regulatory Affairs Working Party, provides a rundown of what members need to know: Systematic Data Collection: Manufacturers must establish and…
Ben Kemp
June 2, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUpcoming Events Regulatory Affairs NewsletterUpcoming Events Regulatory Affairs Newsletter Archive

Become a Certified PRRC – Join Our Expert-Led Virtual Training in June

Join our Upcoming PRRC Training Under the EU MDR and IVDR, the Person Responsible for Regulatory Compliance (PRRC) plays a critical role in ensuring that medical devices meet stringent regulatory standards throughout their lifecycle. Are you prepared to take on that responsibility, or to confirm that your team is ready for it? Join our two-part virtual PRRC training on June…
Ben Kemp
May 28, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUpcoming Events Regulatory Affairs NewsletterUpcoming Events Regulatory Affairs Newsletter Archive

TOPRA – Essentials of In-Vitro Diagnostics Regulatory Affairs

Essentials of In-Vitro Diagnostics Regulatory Affairs 11 July 2025 | London, UK and online Master the fundamentals of IVDs with our training course. It will provide you with the confidence you need to communicate the basics of IVDs in regulatory affairs. There will be a comprehensive overview of the regulatory environment and cover the main regulatory processes and issues surrounding…
Ben Kemp
May 28, 2025
Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

MDSAP Website

MDSAP have launched their refreshed website providing information on the Medical Device Single Audit Program. Official members include TGA Australia, ANVISA, Brazil, Health Canada, PMDA Japan, and US FDA, With the EU, HSA Singapore, MHRA UK, and WHO having joined as official observers, and ANMAT Argentina, Israel’s Ministry of Health, Kenya’s Pharmacy and Poisons Board, Republic of Korea Ministry of…
Ben Kemp
May 28, 2025
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