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European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveMembership NewsMembership News ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA has confirmed EU amendment to MDR will apply in Northern Ireland

MHRA have confirmed that the timeline extensions for the EU MDR will apply in Northern Ireland, and certificates that have been extended will be recognised as valid for placing CE marked devices on the Great Britain market. This comes after the EU passed an amendment to the EU MDR and EU IVDR to amend the transition timelines for medical devices,…
admin
March 31, 2023
Membership NewsMembership News Archive

R&D Tax relief reform changes

Changes are being made for companies that carry out Research & Development (R&D) and claim R&D tax relief under either of two schemes - the Research and Development Expenditure Credit (RDEC) and the small or medium enterprises (SME) R&D relief, and some companies which have made a Patent Box election. Background The two schemes offer generous support to incentivise firms…
Natalie Creaney
March 31, 2023
Membership NewsMembership News Archive

Spotlight on Sustainability: Free Supplier CRP Checking Service from NHS England EXTENDED

NHS England have announced they have extended the free Carbon Reduction Plan Checking Service for suppliers. This service is now available until 30th September 2023. Email your CRP to  england.crp-check@nhs.net. Suppliers will need a Carbon Reduction Plan in place that is compliant with the requirements of PPN 06/21 from April 2023, as detailed in the NHS Supplier Roadmap.
Natalie Creaney
March 31, 2023
Membership NewsMembership News Archive

New i4i grant call from NIHR coming soon – get prepared to apply!

The i4i Product Development Awards (PDA) is seeking applications for a funding call aimed at the research and development of medical devices, in vitro diagnostics, and high-impact patient-focused digital health technologies for ultimate NHS use. This is a great opportunity for BIVDA members looking to secure grant funding on the NIHR platform, with no upper limit on costs. The call…
Natalie Creaney
March 31, 2023
Membership NewsMembership News Archive

RFI – NHS PATHOLOGY TRANSFORMATION – Clinical Pathway Optimisation Automation in Histopathology

This work will help to inform capital and revenue requirements and shape a benefits realisation position for automation. If your company has a solution, or any part of a solution to address the areas detailed in this table, please email helen@bivda.org.uk with the attached completed form. If you do not respond, then there is a possibility that you may not be included in…
Natalie Creaney
March 31, 2023
Membership NewsMembership News Archive

DHSC, Design for Life – Sustainability Grand Challenge – Building a partnership to improve diagnostics sustainability

BIVDA and UK CPI, attended this event which was held at the BEIS conference centre in Victoria on Wednesday. DHSC, OLS, NHS Supply Chain, NHS England, UKRI, Innovate UK, BSI, Axrem, Urology Trade Association, ABHI, NHS Wales, several academic institutions (such as University of Cambridge and University of Exeter) several medtech companies and NHS Trusts were also involved. Design for…
Natalie Creaney
March 31, 2023
Membership NewsMembership News ArchiveNear Patient Testing Working PartyNear Patient Testing Working Party Archive

Point of Care Technologies for use in ambulances

A message from Prof Rick Body, in his role as Director of the Diagnostics and Technology Accelerator (DiTA) in Manchester regarding Point of Care tests for ambulance use – see the link here. What is DiTA? Effectively operating like the MICs but independent of NIHR, to support and catalyse the generation of high quality evidence for new diagnostics and medical…
Ben Kemp
March 24, 2023
Membership NewsMembership News Archive

BIVDA member Pockit Diagnostics pockets top innovation award at Bright Ideas in Health Awards 2022

BIVDA had a fantastic evening at the Bright Ideas in Health Awards 2022 in Newcastle as both our COO, Helen Dent and Head of Regulatory Affairs, Ashleigh Batchen, witnessed BIVDA member Pockit Diagnostics take home the award for “Development of an Innovative Device or Technology” for their LVOne blood test. The award was sponsored by fellow BIVDA member, CPI. This…
Ben Kemp
March 24, 2023
Membership NewsMembership News Archive

Medtech Adoption Pro Forma

Please see a letter from David Lawson, Head of the MedTech Directorate together with an excel form to be completed urgently if you have product(s) that meet the criteria. Don’t submit anything that is not yet available for sale as these won’t be considered, although it is possible that this might become a notification mechanism for the future for products…
Ben Kemp
March 24, 2023
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