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BIVDA Regulatory Working Party update – 17 December 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…
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December 17, 2021
BIVDA involvement with ongoing MHRA regulatory work 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…
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December 9, 2021
Covid-19 Desktop Validation – BIVDA Update 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 Tests would have needed to be approved by 31 October 2021 or withdrawn from the market.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…
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December 3, 2021
2020 statistics released on the bioscience and health technology sectors 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…
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December 3, 2021
BIVDA response: UK Health Security Agency consultation on UK SMI S 12: sepsis and other systemic and disseminated infections Consultations Archive

BIVDA response: UK Health Security Agency consultation on UK SMI S 12: sepsis and other systemic and disseminated infections

The consultation asked for feedback on UK Standards for Microbiology Investigations S 12: sepsis, and other systemic and disseminated infections. This consultation ran from 15 November 2021 to 5pm on 29 November 2021. Consultation response
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December 3, 2021
BIVDA response: GMDN Agency Consultation on specific IVD related GMDN terms Consultations Archive

BIVDA response: GMDN Agency Consultation on specific IVD related GMDN terms

The IVD Team at the GMDN Agency launched a consultation regarding a proposed scaling back of antibody-specific IVD terms within the GMDN. The move would be to consolidate all infectious disease antibody-class specific terms for a particular analyte to a single concept, including total antibody and neutralizing antibody concepts. Consultation response
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December 3, 2021
BIVDA launches its ‘UK Responsible Person Directory’, free-of-charge for members 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…
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December 3, 2021
Government pledges millions to boost the fight against HIV transmission HighlightsHighlights Archive

Government pledges millions to boost the fight against HIV transmission

An important action plan on reducing HIV transmission in England has been published. The ‘Towards Zero: the HIV Action Plan for England - 2022 to 2025’ paper sets out ambitious objectives such as an 80% reduction in new HIV infections in England by 2025. Progress on tackling HIV has been made already, such as the fulfilment of the UNAIDS 90-90-90…
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December 3, 2021
Free Webinar: UK REACH and GB Biocidal Products: Data Sharing, Disputes and Appeals Environmental Working PartyEnvironmental Working Party Archive

Free Webinar: UK REACH and GB Biocidal Products: Data Sharing, Disputes and Appeals

The introduction of UK REACH and GB Biocidal Products has seen the chemicals and biocides industries facing the challenge of new regulatory regimes for the British market, with data sharing being one of the most pressing issues. Date: Wednesday 8 December 2021 - 14.00pm This webinar will address how the new GB legal system will work, and provide practical advice…
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December 3, 2021