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The Border Target Operating Model: Draft for Feedback

The Government, with the support of the Scottish and Welsh Governments, has published the new draft Border Target Operating Model (TOM) which can be found here. The draft Border Target Operating Model proposes a new approach to security controls (applying to all imports), and sanitary and phytosanitary controls (applying to imports of live animals, animal products, plants and plants products) at the…
Natalie Creaney
April 14, 2023
BIVDA updates Regulatory Affairs NewsletterMembership NewsMembership News ArchiveUpcoming Events Regulatory Affairs Newsletter

TOPRA training discount for BIVDA members

TOPRA, The Organisation for Professionals in Regulatory Affairs, host a variety of training in the regulatory space that may be beneficial to BIVDA members. To encourage continued development of regulatory knowledge, we are partnering with TOPRA to offer a discount for BIVDA member organisations. A number of courses are planned this year, with a number involving BIVDA engagement: Regulation of…
admin
April 6, 2023
Membership NewsMembership News Archive

NICE recommends BIVDA member Genedrive’s test

BIVDA is delighted that Genedrive’s genetic test has been officially recommended for use in NICE’s final guidance. The assessment of the test was carried out carried out through NICE’s Early Value Assessment pilot project, which aims to enable earlier access to digital products, medical devices and diagnostics that address national unmet needs in health and social care. We hope to see many more…
Natalie Creaney
April 6, 2023
Membership NewsMembership News Archive

REMINDER: Submissions from members welcomed for the Future Cancer Inquiry

The Future Cancer Inquiry, led by the Health and Social Care Committee, is closing soon (26/4/23) and members are encouraged to submit their cancer diagnostic innovations to us so that we can include them in our submission. The inquiry will look at the innovations with the greatest potential to transform cancer diagnosis and treatment for patients in the short, medium…
Natalie Creaney
April 6, 2023
Membership NewsMembership News Archive

All Wales Pathology Consumables, Equipment, and Instruments Tender ITT

The all Wales Pathology Consumables, Equipment, and Instruments Tender ITT has been released. The deadline for submissions is 12pm on 19/05/2023. Tender Reference:  CLI-OJEU-51547 All Wales Pathology Consumables, Equipment, and Instruments Bravo Reference: itt_101272 Tender documents can be accessed here: http://www.etenderwales.bravosolution.co.uk NHS Wales Shared Services Partnership Procurement Services (NWSSP ProcS), hosted by Velindre NHS Trust, invites tenders on behalf of…
Natalie Creaney
April 6, 2023
Membership NewsMembership News Archive

Media Monitoring: 25th – 31st March

Medical Technology Regulations and the NHS – Commons debate Caroline Dinenage MP, ‘the freedoms afforded by Brexit allow us the opportunity to recognise approvals from any jurisdiction that we deem appropriate’. ‘We have the potential to make the United Kingdom the most attractive place in the world for innovation and, in particular, medical innovation’. ‘Will the Minister assure us that…
Natalie Creaney
March 31, 2023
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,…
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March 31, 2023
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