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Membership NewsMembership News Archive

BIVDA CEO speaks to The Independent about a future wave of non-COVID illnesses

BIVDA CEO Doris-Ann Williams has recently spoken to The Independent, stating that the UK should prepare for a wave of non-COVID deaths from undiagnosed illnesses owing to millions of missed or delayed tests due to the pandemic. Doris-Ann pointed to unreleased BIVDA data which shows that a lack of testing for conditions such as diabetes, heart disease and cancer since…
admin
January 14, 2022
HighlightsHighlights Archive

Media & Parliamentary Monitoring: 10/01 – 14/01

What’s been said in Parliament this week? In a debate on UK Productivity, Bill Esterson MP (Lab) asked why the Government were buying tests from China rather than the UK. He went on to accuse the MHRA of delaying approval to British tests, leading British companies unable to sell their tests at home but able to sell them abroad. Kwasi…
admin
January 14, 2022
COVID-19 TaskforceCOVID-19 Taskforce Archive

BIVDA/ABHI Briefing on CTDA Validation requirements regarding COVID Test Applications

Ahead of the 31 December deadline, BIVDA and ABHI are hosting a joint webinar on the latest COVID-19 Test Desktop Validation developments from the CTDA team for live applications. This will take place on Tuesday 21 December from 10am to 11am. Please register your attendance at this page. There is some important information to share with members which may assist in completing outstanding applications.…
admin
December 17, 2021
Procurement Working PartyProcurement Working Party Archive

Procurement Working Party – Green Paper Consultation response

The Government has published its response to the consultation from 10th March 2021. The full response can be found Green Paper Consultation Response  - Consultation response published in December 2021 A comparison to BIVDA’s submission will be issued to members of the Procurement Working party next week. We will be examining the implications in more detail in the new year…
admin
December 17, 2021
Regulatory Affairs Working PartyRegulatory Affairs Working Party Archive

BIVDA Regulatory Working Party update – 17 December 2021

BIVDA held our Regulatory Affairs working party on Friday 17th December. The meeting provided an update on the ongoing and future regulatory work being conducted within the IVD sector. This was opened by a presentation from Richard Saunders, our chair, on the European situation. Numerous guidance pages have been drafted by MedTech Europe to ease compliance to the IVDR. As…
admin
December 17, 2021
Regulatory Affairs Working PartyRegulatory Affairs Working Party Archive

BIVDA involvement with ongoing MHRA regulatory work

BIVDA takes part in the monthly MHRA/Trade Association meeting which allows for open dialogue between everyone involved. Recently, this has been focussed on the ongoing regulatory changes in the UK. This meeting is BIVDA’s opportunity to raise any concerns from members and get key insight into the regulatory changes in the UK. The last meeting was on 2 December, providing…
admin
December 9, 2021
Membership NewsMembership News Archive

Covid-19 Desktop Validation – BIVDA Update

The legislation 'The Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021' came into effect on 1 September 2021 with the deadline for submissions by suppliers being the 31 August 2021. Tests would have needed to be approved by 31 October 2021 or withdrawn from the market. On the 20 October, suppliers were written to and informed that due to…
admin
December 3, 2021
Membership NewsMembership News Archive

2020 statistics released on the bioscience and health technology sectors

The Departments for Health, Business and Office for Life Sciences have released statistics from 2020 on the performance of the bioscience and health technology sectors. The figures show strong UK activity in these fields, with a significant input from SMEs. In fact, 85% of the businesses in the industry are SMEs. Another key statistic is that the UK life sciences…
admin
December 3, 2021
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