Each year, BIVDA organises a Christmas lunch for members of the Regulatory Affairs Working Party, as well as a charity appeal. This year's charity is Starlight, a national children's charity that supports children with serious illnesses by providing health play services and events. This year they are asking donors to ‘Sponsor a star’ on Oxford Street ‘to make a…
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This NICE guideline covers suspected sepsis: recognition, diagnosis and early management – source control, rapid antigen tests, indicators of organ hypoperfusion, intravenous fluids, and vasopressors in the NEWS2 population. You can now comment on this draft scope. The scope defines what the guideline will (and will not) cover. The consultation closes at 5pm, Thursday 23 November 2023.
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The Seminar covered the following topics: MHRA Software Roadmap with Johan Ordish (MHRA) MHRA IVD Roadmap, UKCA, and the Life Science Review with Ashleigh Batchen (BIVDA), Tom Beale (Agilent Technologies) and Camilla Fleetcroft MDCG Roadmap with Andrew Rutter (QuidelOrtho) Class D IVDs with Erica Conway (MCRA) BSI Standards with Rob Turpin (BSI) US Regulatory Process Stuart Angell (IVDeology) The event…
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Please see below a Q and A in reference to a UKRP. Is it possible to transfer to a UK agent? If transfer is possible, will the procedures and registered medical devices be transferred as well? If transfer is not possible, should the medical device be registered under the name of a new agent? Only one UKRP is permitted for…
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Dear members, BIVDA held a joint in-person workshop with the MHRA on the future IVD Roadmap. This took place on 10 February at the MHRA offices. The aims of this were to understand: The IVD ecosystem The gaps in the landscape MHRA’s role in this The needs for pre-market support The barriers and enablers for market access The workshop was…
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