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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
ConsultationsConsultations ArchiveExternal Affairs Working PartyExternal Affairs Working Party ArchiveInfectious Diseases Working PartyInfectious Diseases Working Party ArchiveRegulatory Affairs Working PartyRegulatory 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.
Dawn
November 10, 2023
Membership NewsMembership News ArchiveRegulatory Affairs Working PartyRegulatory 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…
Natalie Creaney
March 17, 2023
Membership NewsMembership News ArchiveRegulatory Affairs Working PartyRegulatory 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…
Ben Kemp
February 24, 2023
Regulatory Affairs Working PartyRegulatory 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…
Natalie Creaney
January 13, 2023
Regulatory Affairs Working PartyRegulatory Affairs Working Party Archive

Regulatory Affairs Working Party Meeting and Lunch – Friday 9 December 2022

Each year, BIVDA organises a Christmas dinner for members of the Regulatory Affairs Working Party, as well as a charity appeal. This years charity is FareShare, who redistribute surplus food to charities that turn it into meals and provide much needed support to communities in need. Please donate here. The Christmas lunch will be held at Ponti's restaurant which is located just off Oxford…
Natalie Creaney
November 25, 2022
Membership NewsMembership News ArchiveRegulatory Affairs Working PartyRegulatory Affairs Working Party Archive

BIVDA UKCA sub-group

BIVDA previously ran a UKCA sub-group which was an off-shoot of the Regulatory Affairs Working Party. This group hasn’t met recently due to insufficient content. Now that we have slightly more clarity on the UKCA regulations and MHRA have committed to introducing timeline legislation in Spring 2024, we thought this was the opportune time to restart this group. The UKCA…
Ben Kemp
November 3, 2022