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MHRA Update from BIVDA’s 2025 Regulatory Affairs Seminar

BIVDA welcomed Dr Rob Reid and Nadine Neale from the MHRA to BIVDA's Regulatory Affairs Seminar last week. They provided updates on the latest MHRA activity including the MHRA Fees consultation, GB Post Market Surveillance, the Pre-Market SI Consultation, and the AI Airlock Pilot, which members will find useful. We have outlined all updates below: MHRA Fees Consultation – The…
Ben Kemp
February 19, 2025
Membership NewsMembership News ArchiveNear Patient Testing Working PartyNear Patient Testing Working Party Archive

Join the NPT Working Party for CPI partnership plan to accelerate NPT – 6 March 2025

Have you signed up for the latest Near Patient Testing (NPT) working party meeting yet?  On 6th March, BIVDA will be hosting the next NPT working party meeting, in person, at the BIVDA offices. We are pleased to be welcoming CPI, part of UK Government’s Catapult network of innovation centres, to talk about how they have been tasked by the…
Ben Kemp
February 18, 2025
Membership NewsMembership News Archive

BIVDA 2025 Regulatory Affairs Seminar Round-Up

Thank you to everyone who attended BIVDA's sold-out 2025 Regulatory Affairs Seminar and provided excellent feedback. Bringing together regulatory affairs experts from across the globe underlined the importance of  hearing international perspectives, assessing what works and what doesn't, and agreeing on the right direction of travel.medboard Most of all, distilling expertise into a polished two-day event focused on developing regulatory…
Ben Kemp
February 18, 2025
ConsultationsConsultations ArchiveMembership NewsMembership News Archive

Welsh Government Consultation: Extending the UK Emissions Trading Scheme (ETS) cap beyond 2030

The Welsh Government is seeking views on extending the UK Emissions Trading Scheme (ETS) beyond the end of Phase I (midnight on 31 December 2030). This fulfils the commitment made in December 2023 within the UK Emissions Trading Scheme long-term pathway to consult on the extension of the Scheme. This consultation proposes options and seeks views on: extending the UK…
Ben Kemp
February 18, 2025
HighlightsHighlights Archive

NHS rolls out HIV opt-out testing to 30 more A&Es

Under a new expansion plan, 30 more A&Es will start testing for the infectious disease in hospital emergency departments (ED) via the revolutionary NHS Blood Borne Virus Opt-out Testing programme (BBV). Under the programme, people visiting an ED are offered a discreet test which screens for the HIV, Hepatitis B and Hepatitis C viruses when full bloods are taken. If…
Ben Kemp
February 18, 2025
Membership NewsMembership News Archive

Last chance to attend launch of HealthTech Research Centre in In-Vitro Diagnostics

Last chance to attend launch of HealthTech Research Centre in In-Vitro Diagnostics featuring BIVDA's Helen Dent. The event takes place this Friday 21 February 2025 at 09:30 - 15:00 at the Storey Club - Paddington Central. HRC IVD is a centre of expertise offering research and navigation services for innovators in all stages of IVD development. Hosted by Imperial College…
Ben Kemp
February 18, 2025
HighlightsHighlights Archive

Health Secretary confirms AMR remains government priority

In an exchange between Shadow Health Minister Dr Caroline Johnson and Health Secretary Wes Streeting, Mr Streeting reiterated the Government's commitment to tackling antimicrobial resistance (AMR). Dr Johnson noted the high number of antimicrobial-resistant infections in the UK and the growing risks derived from the war in Ukraine. She asked whether the Government had a plan to tackle AMR in…
Ben Kemp
February 18, 2025
HighlightsHighlights Archive

New NHS England Chair set to be named

Dr Penny Dash has been named as the Government’s preferred candidate for the next chair of NHS England. She is set to replace current chair, Richard Meddings, in April. Wes Streeting, the Secretary of State for Health and Social Care, has invited the Health and Social Care Committee to hold a pre-appointment scrutiny hearing with Dr Dash. Dr Dash is…
Ben Kemp
February 18, 2025
Membership NewsMembership News Archive

Government publishes National Procurement Policy Statement (NPPS)

Last week, the Government published its National Procurement Policy Statement (NPPS), setting out the strategic priorities for public procurement. This statement will come into effect on 24 February 2025, alongside the introduction of the Procurement Act 2023 and is intended to outline the government priorities to be achieved through the implementation of the Act. In addition 2 new PPNs have…
Ben Kemp
February 18, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA Update (WC 10 Feb)

Current approaches to product marking Page summary: Guidance on product marking, including the continued recognition of certain EU requirements, such as CE marking, for specific product sectors. Change made: First published. Time updated: 7:00am, 3 February 2025 MHRA asks for views on proposed guidance to support the safe regulation of new personalised cancer therapies   Page summary: The draft MHRA…
Ben Kemp
February 18, 2025