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 Tests would have needed to be approved by 31 October 2021 or withdrawn from the market.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