BIVDA would like to update members on a number of changes to working party chairs and vice chairs. Regulatory Affairs Working Party Alison Gilles, Leica BioSystems, steps up at the Regulatory Affairs Working Party as Vice Chair, meaning that we’re back to full complement. UKCA Subgroup Emma Barringer is moving from chairing the Environmental WP to chairing the UKCA Subgroup.…
Ben KempMay 19, 2025
Last week, MHRA updated the PMS and Vigilance guidance page. They intend to continue to accept reporting for NI using the EU MIR and will transition to using 7.3.1 as per the EU deadline, however for GB reporting there is a new GB Schema that will be introduced and will need to be used from the date of application of…
Ben KempMay 19, 2025
Guidance on what happens when Intensified Official Controls are triggered at the EU Border The Department for Environment, Food & Rural Affairs (Defra) has published new guidance aimed at businesses exporting animal products from Great Britain to the European Union. This guidance sets out the procedures and requirements for exporters if their consignments trigger Intensified Official Controls (IOCs) or Imposed…
Ben KempMay 15, 2025
Corrigendum to Regulation (EU) 2024/1781 of the European Parliament and of the Council of 13 June 2024 establishing a framework for the setting of ecodesign requirements for sustainable products, amending Directive (EU) 2020/1828: EUR-Lex - 32024R1781R(02) - EN - EUR-Lex
Ben KempMay 15, 2025
The EU Radio Equipment Directive impacts devices using radio equipment, including IVD instruments with Wi-Fi, Bluetooth, Cellular or Near Field Communication, including RFID. The EU directive applies both in the EU and to products placed in Northern Ireland. GB Radio Equipment Regulations based on the EU assimilated law as at 1st Jan 2021 (as amended in UK Law): Address EU…
Ben KempMay 15, 2025
Team NB have published their position paper on the reclassification of SARS-CoV-2: www.team-nb.org/wp-content/uploads/2025/04/Press-Release-TEAM-NB-COVID-test-classification-change-20250404.pdf
Ben KempMay 15, 2025
Government’s tech reform to transform cancer diagnosis Page summary: Cancer 360 brings patient data into one central system, so clinicians can prioritise those most in need and see patients quicker Change made: First published. Time updated: 12:01am, 4 May 2025 Primary Care Utilisation and Modernisation Fund 2025 to 2026 Page summary: A full list of schemes included in the Primary…
Ben KempMay 15, 2025