Health Canada have issued guidance regarding Biotin interference with Immunoassays. Learn more here.
Ben KempJanuary 17, 2025
Regulation of devices in Northern Ireland Page summary: Information about the EU Regulations and their implementation in Northern Ireland Change made: Update to ‘Clinical investigations and performance studies in Northern Ireland’ section. Medical devices: UK approved bodies Page summary: UK approved bodies listed under Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002). Change made: Updated BSI Assurance…
Ben KempJanuary 17, 2025
Make an entry summary declaration using the Import Control System 2 Page summary: Check when you need to use this system to make an entry summary declaration for goods into Northern Ireland from Great Britain, or into Northern Ireland from outside the EU. Change made: Information about when the new arrangements for parcels under the Windsor Framework come into effect…
Ben KempJanuary 17, 2025
Regulators: professional guidance and tools Page summary: Resources for regulators. Change made: Link added to guidance on EU Regulation 2023/988 on General Product Safety. Time updated: 9:36am, 7 January 2025 Designated standards: PPE Page summary: Notices of publication and a consolidated list for designated standards for personal protective equipment (PPE). Change made: Notice of publication amended and consolidated list updated.…
Ben KempJanuary 17, 2025
New regional skills projects to bolster UK cyber defences and deliver on Plan for Change Page summary: More than 30 projects across England and Northern Ireland will deliver targeted support to boost the UK’s cyber resilience. Change made: First published. Time updated: 12:01am, 8 January 2025 Evaluation of the Northern Ireland Cyber AI Hub programme Page summary: A report setting…
Ben KempJanuary 17, 2025
DBT and CMA memorandum of understanding: international cooperation Page summary: Memorandum of understanding between the Department for Business and Trade (DBT) and the Competition and Markets Authority (CMA) regarding international cooperation on competition and consumer law enforcement. Change made: First published. Time updated: 12:00pm, 6 January 2025 Creating a smart data economy Page summary: Through championing smart data, we are…
Ben KempJanuary 17, 2025
Check the CHED reference in customs declarations Please ask your customs agent to carefully check the CHED import notification reference that they are adding into a customs declaration for your consignments. CHEDs submitted on IPAFFS from 1 January 2025 will have a ‘2025’ prefix. Customs declaration with incorrect ‘2024’ CHED references may cause delays in processing or incorrect holds to appear…
Ben KempJanuary 17, 2025
MDCG 2023-3 rev.2 - Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 under Regulation (EU) 2017/746 - January 2025
Ben KempJanuary 17, 2025
MDCG have update their guidance MDCG 2022-3 rev.1 - Verification of manufactured class D IVDs by notified bodies (December 2024). Find out more here.
Ben KempJanuary 16, 2025