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Ben Kemp

MHRA to extend UKCA date of application by 12 months Membership NewsMembership News Archive

MHRA to extend UKCA date of application by 12 months

MHRA have distributed a letter to industry and the Devolved Administrations in relation to the date of application of the new UKCA regulatory regime. The letter confirms that the date of application will be extended by 12 months until July 2024. This means that there will continue to be unilateral recognition of the CE mark until this date, and CE…
Ben Kemp
October 21, 2022
New NHS Genomics Strategy released Membership NewsMembership News Archive

New NHS Genomics Strategy released

The NHS have released a comprehensive strategy for embedding genomics in the NHS over the next 5 years. It is their intention to accelerate the embedding of genomic medicine across the NHS, therefore providing a world leading, equitable service to populations and individuals. In the report, a number of ambitions have been outlined, including: creating an innovative, world-leading genomics service…
Ben Kemp
October 21, 2022
France Biotech & Eucope Regulatory Survey Regulatory Affairs Working PartyRegulatory Affairs Working Party Archive

France Biotech & Eucope Regulatory Survey

France Biotech is conducting a field survey with Eucope. This survey is intended to highlight the difficulties encountered by small and medium-sized companies of Medtech sector to comply with the clinical and regulatory requirements of the MDR. They require more foreign respondents to ensure a significant European representativeness, with a deadline of 11 November 2022. The survey can be accessed…
Ben Kemp
October 14, 2022
Milestone reached as CDCs deliver 2 million extra scans, tests and checks HighlightsHighlights Archive

Milestone reached as CDCs deliver 2 million extra scans, tests and checks

Community diagnostic centres (CDCs) have delivered more than 2 million vital tests, checks and scans for patients, with a further 10 centres now approved, the Health and Social Care Secretary has announced. The one-stop shops, backed by £2.3 billion in government funding, offer a range of services in the heart of communities, making tests more accessible for patients. Based in…
Ben Kemp
October 14, 2022
Government pledges nearly £1bn to boost innovation, growth and improve patient safety HighlightsHighlights Archive

Government pledges nearly £1bn to boost innovation, growth and improve patient safety

The Government have today announced an £800 million investment into research centres, to be allocated by the NIHR, and will bring together scientists to create an environment where experimental medicine, new diagnostics and patient safety research can thrive. This boost to the country’s research infrastructure will see further investment in scientific expertise which supports access to innovative technology and novel…
Ben Kemp
October 14, 2022
New BIVDA market audit report available Market DynamicsMarket Dynamics ArchiveMembership NewsMembership News Archive

New BIVDA market audit report available

A summary report of the BIVDA market audit to June 2022 is available on request to participants. The report details the size and trends in the UK IVD market in the last year and highlights the impact of the Coronavirus pandemic on testing across all disciplines, including indication of companies that have gained and lost market share as a result.…
Ben Kemp
October 14, 2022
Life Sciences Access Academy – webinar links for members Membership NewsMembership News Archive

Life Sciences Access Academy – webinar links for members

Each month, two LSAA webinars are available exclusively to BIVDA members. This month is sustainability-focused with both webinars covering the topic.   Webinar 1: Sustainability: Becoming Carbon Literate Michelle Sullivan will be answering the question, “What does sustainability actually mean?” in an evidence-based way. She will also be discussing the global scale of the challenge, what we must do and…
Ben Kemp
October 14, 2022
Diagnostics Industry Advisory Group (DIAG) Membership NewsMembership News Archive

Diagnostics Industry Advisory Group (DIAG)

BIVDA takes part in a smaller steering group with regards to agenda setting and structure with NHS England at intermittent intervals. Most recently, Helen provided some thoughts and challenges directly to NHS England about the need to be more specific in pathways, infrastructure for capillary testing and identifying clinical need better. This will then inform NHS implementation cycles and help…
Ben Kemp
October 14, 2022