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BIVDA attends joint APPG event on the Rare Disease Framework

On Tuesday, BIVDA attended a joint event organised by the All Party Parliamentary Groups for Life Sciences, and for Rare, Genetic and Undiagnosed Conditions. The central topic of the event was the implementation of the 'UK Rare Diseases Framework' and the adjustment of this legislation in relation to patient needs and greater understanding of rare diseases. While the population of…
Ben Kemp
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 Tests would have needed to be approved by 31 October 2021 or withdrawn from the market.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
Membership NewsMembership News Archive

BIVDA launches its ‘UK Responsible Person Directory’, free-of-charge for members

BIVDA has launched its new ‘UK Responsible Person Directory’ this week, a benefit to our member companies who wish to advertise their UKRP status to IVD and medical device manufacturers across the globe. To comply with the existing UK regulations, non-UK manufacturers of IVDs and medical devices need to appoint a UKRP to act on their behalf. The Directory is…
admin
December 3, 2021
Membership NewsMembership News Archive

100 Days Mission: First Implementation Report released

Following the announcement of the 100 Days Mission earlier this year, G7 Chief Scientific Advisers have published the first implementation report for G7 Leaders. The report emphasises the need to harness rapid advances in science and technology and strong public-private collaboration to fill the gaps in our current arsenal of DTVs. Many recommendations pertinent to the diagnostics industry are made…
admin
December 3, 2021
Membership NewsMembership News Archive

BIVDA responses to four consultations

Over the past week, BIVDA have submitted responses to four separate consultations. We have published each of these responses for Members, along with links to information on the consultation. • MHRA: Consultation on the future regulation of medical devices in the United Kingdom • MHRA: Response submitted 25 November 2021 • UKHSA: UK SMI S 12: sepsis and other systemic…
admin
December 3, 2021
Membership NewsMembership News Archive

LifeArc pledges £1.3 billion by 2030 to establish new medical innovations

This represents a doubling of LifeArc’s annual spend – a significant boost to the UK life sciences sector – and signals the charity’s intention to play a key role in establishing the UK as a global life sciences superpower. The charity has been noted as an early-stage translation specialist and seeks to accelerate scientific advances in order to bring preventative…
admin
November 26, 2021
Membership NewsMembership News ArchiveProcurement Working PartyProcurement Working Party Archive

BIVDA is pleased to announce a working partnership with IntelliCentrics UK

This partnership is a sector leading initiative, intended to simplify the process which is becoming increasingly prominent in Trusts. Working closely with NHS and Private hospitals through Intellicentrics, BIVDA will be able to support members to conduct their business in customer accounts with appropriate entry criteria relative to the job roles they perform, Credentialling is important for hospitals and patients…
admin
November 26, 2021
Membership NewsMembership News Archive

BIVDA response submitted to MHRA UKCA consultation

The consolidated BIVDA response to the MHRA consultation on the future regulation of medical devices in the United Kingdom was submitted on 25 November. This was a full response to all sections relevant to IVDs, and was based on feedback provided by members. BIVDA have also drafted a cover letter to be provided to MHRA separately, supplementing the information provided…
admin
November 26, 2021
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