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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
December 2, 2022 in Regulatory Affairs Working Party, Regulatory Affairs Working Party Archive

UKCA sub-group has resumed

The UKCA sub-group met on 29 November for the first time in over a year. This group had been paused due to insufficient information on UKCA in recent time but has now been restarted as we are expecting discussions around UKCA and the future requirements to increase substantially. The meeting itself had a fantastic turnout and a lot of interesting…
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November 25, 2022 in Regulatory Affairs Working Party, Regulatory 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…
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November 18, 2022 in Regulatory Affairs Working Party, Regulatory Affairs Working Party Archive

BIVDA response to the WEEE Compliance Fee Methodology 2022 consultation

Regulatory Affairs Manager Ashleigh Batchen has compiled a comprehensive response to the WEEE Compliance Fee Methodology 2022 consultation. The consultation response can be read here.
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November 3, 2022 in Membership News, Membership News Archive, Regulatory Affairs Working Party, Regulatory 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…
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October 21, 2022 in Membership News, Membership News Archive, Regulatory Affairs Working Party, Regulatory 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.…
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