Membership News Archive

The letter sent by BIVDA on behalf of members has been escalated with UKHSA separately to the team conducting the CTDA process. We have spoken directly to the procurement and market engagement teams, and our concerns have been acknowledged, but with no indication of a resolution at this stage. We have made it very clear that we expect a formal…

The 'COVID Unsung Heroes Awards' is an initiative being led to spotlight the extraordinary contribution made by women in the STEM space during the COVID-19 pandemic. BIVDA is delighted to support this excellent opportunity to recognise the efforts of women during these unprecedented times who strove to help improve lives and health outcomes. There are several award categories for these…

Sir David Sloman has been chosen to become NHS England’s Chief Operating Officer for an interim period after a recruitment process failed to find a substantive appointment. Since the previous COO Amanda Pritchard was promoted to Chief Executive in August, Mark Cubbon has acted as interim COO. Sir David has been in the post of NHS England’s London director, and…

The European Stakeholder Group has issued a joint statement calling for clarity on the United Kingdom’s association to Horizon Europe as soon as possible. A formalisation of the UK's involvement and access to the Horizon Europe programme has not yet taken place following the UK's departure from the European Union. Horizon Europe is the EU’s key funding programme for research…

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…

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 Tests would have needed to be approved by 31 October 2021 or withdrawn from the market.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…

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…

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…

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…

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…