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RCPath and Biomerieux webinar: Diagnostics as a cornerstone of the UK National Action Plan for AMR

The Royal College of Pathologists, in partnership with BIVDA member Biomerieux, are hosting a webinar on 11th September at 12:30 titled 'Diagnostics as a cornerstone of the UK National Action Plan for Antimicrobial Resistance (AMR). In this webinar, Amelia Worley, Policy Lead for AMR, Sepsis and IPC in the Department of Health and Social Care (DHSC), will give an overview of…
Ben Kemp
August 5, 2025
Membership NewsMembership News Archive

BIVDA welcome EarSwitch as new members!

We are thrilled to welcome EarSwitch as new BIVDA members! EarSwitch Ltd is developing improved accuracy and racially inclusive medical monitoring for physiological parameters/'vital signs', to enable existing device manufacturers to improve their products. Their first target is as an alternative to current pulse oximeters, as many have been shown to be inaccurate for people with brown or black skin.…
Ben Kemp
August 4, 2025
Membership NewsMembership News Archive

BIVDA welcome 52North as new members!

We are pleased to announce 52North - creators of Neutrocheck® as new BIVDA members! 52North is a medical technology company on a mission to make urgent care pathways safer and more effective. Awarded breakthrough status for its first product Neutrocheck® by the UK Government in 2024, 52North builds in vitro diagnostic and digital solutions to transform patient journeys in urgent care.…
Ben Kemp
July 29, 2025
Membership NewsMembership News Archive

BIVDA member spotlight: Hugo Technology

Who we are Hugo Technology, founded in 2001, is a leading Independent Service Organisation (ISO) specialising exclusively in technical services and solutions support for medical and laboratory device/systems Original Equipment Manufacturers (OEMs). We’re not a third-party contractor, we partner directly with OEMs. We currently process more than 35,000 work orders per year. What we do With two state of the…
Ben Kemp
July 29, 2025
Membership NewsMembership News Archive

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
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