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Medicines and Medical Devices Act 2021 – Stakeholder Survey

The Medicines and Healthcare products Regulatory Agency (MHRA), in collaboration with the Department of Health and Social Care (DHSC), is conducting a review of the UK’s medicines and medical device regulatory framework, and they are seeking input from stakeholders across the sector, including patients and the public. The review is a statutory obligation under the Medicines and Medical Devices Act 2021 and…
Ben Kemp
July 29, 2025
Membership NewsMembership News Archive

Innovate UK Health & MedTech Global Mission to Singapore 2025 – applications now open

Innovate UK’s Global Business Innovation Programme consists of a ‘Get ready’ preparation phase, 5-day innovation visit to Singapore focused on Health & Medical Technologies, an ‘Exploit the opportunity’ workshop and support from an Innovate UK innovation and growth specialist. All phases of the programme are aimed at helping your business maximise the opportunities identified and develop innovation projects with partners…
Ben Kemp
July 29, 2025
Membership NewsMembership News ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

CTDA (Coronavirus Test Device Approvals) Update

The MHRA recently announced that the current CTDA (Coronavirus Test Device Approvals) process for approval of SARS-CoV-2 tests is intended to be repealed with the introduction of the pre-market statutory instrument. Once Parliament agrees the statutory instrument, the MHRA have confirmed that the CTDA regulations will no longer apply from when the statutory instrument is made into legislation. They anticipate this…
Ben Kemp
July 29, 2025
Membership NewsMembership News Archive

BIVDA response to articles concerning the UK’s private diagnostic testing market

Members will have seen articles from outlets including the BBC last week regarding the UK's private diagnostic testing market. BIVDA wishes to respond to these items. In Vitro Diagnostics are a key part of any health system. Before being placed on the market, tests are reviewed by the Medicines and Healthcare products Regulatory Agency (MHRA) to ensure they are safe…
Ben Kemp
July 29, 2025
Membership NewsMembership News Archive

Register for CPI’s Innovation in MedTech and Diagnostics Conference 2025: Connecting the Ecosystem

BIVDA members CPI are holding their two-day MedTech and Diagnostics Conference 2025: Connecting the Ecosystem on Tuesday 21 October 2025 at 09:00. The conference will explore the future of diagnostics and healthcare delivery in the UK, spotlighting the nation’s strengths in NHS clinical excellence, innovative R&D, and advanced wound care. The agenda features keynote presentations on the next decade of…
Ben Kemp
July 22, 2025
ConsultationsConsultations ArchiveMembership NewsMembership News Archive

DHSC’s Design for Life Industry Survey on Remanufacture of Class I Single-Use Medical Devices

DHSC has published its Design for Life Industry Survey exploring remanufacture of Class I medical devices for members to provide feedback. To recap the context, the survey is being conducted by the Design for Life programme at DHSC to explore the opportunities and implications of remanufactured single-use Class I medical devices for the GB market. The Design for Life Roadmap highlighted remanufacture…
Ben Kemp
July 22, 2025
Membership NewsMembership News Archive

Health Service Journal recognises the need for reform in Pathology Managed Services Procurement

On Friday, HSJ published an article which highlighted the challenges with procurement in Managed Services for Pathology and signposted to the Call for Evidence that has been launched with DHSC. The article headlines with the extent of legal challenge in pathology procurements and goes on to lay out the impact this has on costs of the service and ultimately the…
Ben Kemp
July 16, 2025
Membership NewsMembership News Archive

Centre for Advanced Diagnostics Development and Application (CADDA) Knowledge Transfer Voucher (CKTV) Funding Events

Up to £50,000 is available for collaborative projects that advance diagnostics development and application. CADDA will hold three Café events to support the current live funding call. These events offer a relaxed opportunity to: Learn more about the funding call and what we’re looking for: - Ask questions about the call - Connect and network with fellow members - Meet potential partners…
Ben Kemp
July 16, 2025
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