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Regulatory Affairs Working Party

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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
Membership NewsMembership News ArchiveRegulatory Affairs Working PartyRegulatory Affairs Working Party Archive

Regulatory Affairs Working Party Seminar 2022

On 13 and 14 October, we held our annual Regulatory Affairs Working Party Seminar. This went very well (it wouldn’t be an event without some slight technical issues), with a fantastic turn out. BIVDA would like to thank all of our speakers, the Regulatory Affairs Working Party team, and all of the attendees for making it such a positive event.…
Natalie Creaney
October 21, 2022
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
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