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New paper highlights overlap in EU and US requirements to support efficient compliance

Members may find this white paper useful in ascertaining EU IVDR clinical evidence requirements and how manufacturers can efficiently comply. It is imperative that manufacturers do not underestimate the time required to source the right clinical evidence for their products. As the risk to individual and public health increases with each device classification under the IVDR, the corresponding conformity assessment…
Ben Kemp
April 8, 2022
Membership NewsMembership News Archive

NHS England updated the Trade Association forum with regards to their Evergreen programme

From April 2022, the first Sustainability Supplier Roadmap Milestone was reached with the adoption of PPN 06/20, which is taking Account of Social Value in the Award of Central government Contracts. As a reminder, PPN 06/20 will be included in all tenders from 1st April 2022, with all contracts requiring a climate change question within the 10% minimum weighting criteria.…
Ben Kemp
April 8, 2022
Membership NewsMembership News Archive

IVDeology hosting training session on IVD Regulation

IVDeology are providing a full day training session on an introduction to IVD regulation in Europe and the UK. The agenda covers the framework of the IVD Regulation in Europe, quality management system requirements to meet this legislation, UKCA marking requirements according to the latest information, and the chance to discuss your own specific enquiries in the Q&A session. The…
Ben Kemp
April 8, 2022
Membership NewsMembership News Archive

BIVDA member company QuantuMDx wins two Bionow Awards 2021

Congratulations to BIVDA member company QuantuMDx on their winning two Bionow Awards 2021 at the ceremony held on Thursday night. The company was shortlisted for three awards, winning two in total: Project of the Year (for their efficient manufacturing of the Q-POC™ product range, and Promising Technologist of the Year (Molly Jowsey, Senior Mechanical Engineer). BIVDA congratulates the team on…
admin
April 1, 2022
Membership NewsMembership News Archive

BIVDA meets with Genomics England, NHS England and the Office for Life Sciences to discuss future engagement on genomics

This week Doris-Ann and the Chair of the Genomics Working Party, Dr Philip Beer, had a meeting with the Chief Executive of Genomics England (GEL), Chris Wigley, the deputy director for Genomics at NHS E&I, Alexandra Pickard and the head of Innovation & Growth at the OLS, Colin Wilson. This as following the recent meeting with the working party to…
admin
April 1, 2022
Membership NewsMembership News Archive

Update from Department of International Trade

The DIT is working with other government departments to ensure supply chain resilience and the coordination of the UK’s response with regards to the Ukraine Crisis and details can be found here.  Members can find updates on other key updates in the links below. UK-US Dialogue to boost relationship Joint Statement of future of Atlantic Trade UK and US resolve…
admin
April 1, 2022
Membership NewsMembership News Archive

Latest Information relating to the Ukraine crisis

Members were asked to provide details of products they wish to donate. The DHSC would like to receive offers of types of tests for donation, the number of tests available, and the delivery and collection of tests. Members are invited to send their offers to Helen. BIVDA and the DHSC are incredibly grateful for the continued interest in providing humanitarian…
admin
April 1, 2022
Membership NewsMembership News Archive

Join the free webinar on how to Track your Carbon

Do you want to know how to calculate your organisations carbon footprint? Do you need a compliant carbon reduction plan for tenders? If the answer is YES, then join a free-of-charge webinar on Tuesday 5 April at 10am. Facilitated by industry experts, the webinar will: - Explain the current guidelines and requirements around Net Zero and PPN 06/21 Demystify the…
admin
April 1, 2022
Membership NewsMembership News Archive

MedTech Europe UK Workshop

The session was introduced with a summary of the EU-UK Trade and Cooperation Agreement (TCA) which provides the basis for how the UK is operating post-Brexit. Notably, this agreement does not include mutual recognition of medical devices or IVDs, which is why the UK is now developing our own regulatory regime. The agreement entered into force on 1 April 2021.…
admin
April 1, 2022
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