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Regulatory Affairs Working Party Meeting & Christmas Lunch 2023

  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…
Natalie Creaney
December 1, 2023
November 10, 2023 in Consultations, Consultations Archive, External Affairs Working Party, External Affairs Working Party Archive, Infectious Diseases Working Party, Infectious Diseases Working Party Archive, Regulatory Affairs Working Party, Regulatory Affairs Working Party Archive

NICE guideline on suspected sepsis – consultation

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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March 17, 2023 in Membership News, Membership News Archive, Regulatory Affairs Working Party, Regulatory Affairs Working Party Archive

BIVDA Regulatory Affairs Spring Seminar took place on 8 March

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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March 10, 2023 in Regulatory Affairs Working Party, Regulatory Affairs Working Party Archive

UK medical device agents and UKRP registration

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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February 24, 2023 in Membership News, Membership News Archive, Regulatory Affairs Working Party, Regulatory Affairs Working Party Archive

BIVDA held joint workshop with MHRA on IVD Roadmap

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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January 13, 2023 in Regulatory Affairs Working Party, Regulatory Affairs Working Party Archive

Government publishes review of the Coronavirus Test Device Approvals (CTDA) process

On 29 December, the UK Health Security Agency published their statutory review of the CTDA process. The CTDA process was introduced to ensure that antigen and molecular Covid-19 tests were assessed for performance before being put into the UK market, intending to increase the quality of UK tests. The overarching theme of the review is summarised: “It is clear that…
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