Dear Members, Team NB have published their position paper on the demonstration of safety and performance for combinational Use of Reagent Devices with other Equipment Team-NB Position Paper on Demonstration of Safety and Performance for Combinatorial Use of Reagent Devices with other devices or Equipment - team-nb
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February 27, 2026 in European Commission Updates Regulatory Affairs Newsletter, European Commission Updates Regulatory Affairs Newsletter Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive
EU funding available for health research
š£ EU funding available for health research - check out the open calls for proposals under #HorizonEU! https://lnkd.in/erHNvAQa šļø Deadline: 16 April
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February 20, 2026 in European Commission Updates Regulatory Affairs Newsletter, European Commission Updates Regulatory Affairs Newsletter Archive, Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive
CELEX:32026R0382: Council Regulation (EU) 2026/382 of 11 February 2026 amending Regulation (EC) No 1186/2009 as regards the elimination of the threshold-based customs duty relief
Dear Members, if you make shipments to the EU, please see the revised EU threshold-based customs duty relief below. CELEX:32026R0382: Council Regulation (EU) 2026/382 of 11 February 2026 amending Regulation (EC) No 1186/2009 as regards the elimination of the threshold-based customs duty relief for shipments with intrinsic value not exceeding ā¬150.00 View article...
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February 6, 2026 in European Commission Updates Regulatory Affairs Newsletter, European Commission Updates Regulatory Affairs Newsletter Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive
EU – Update – Harmonised Standards list updates
Dear Members, please see below the update that ISO 17665:2024 and ISO 18113:2024 series have been added to the list of EU IVDR harmonised standards. OJ:L_202600197:EN:TXT.pdf Mario Gabrielli Cossellu ā¢ 1st š£ Two new Commission Implementing Decisions on references of #Harmonised #Standards in support of the #EU #Regulations on #MedicalDevices (#MDR) and #InVitroDiagnosticMedicalDevices (#IVDR) have been adopted on 28 January…
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January 12, 2026 in European Commission Updates Regulatory Affairs Newsletter, European Commission Updates Regulatory Affairs Newsletter Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive
Team NB Position Paper to the proposed Annex VII – Commission implementing regulation draft
Dear members, please find this Team NB Position Paper regarding the EC Annex VII ā Commission Implementing Regulation Draft. This is in response to the European Commission proposed draft Implementing Regulation EUR-Lex - Ares(2025)11081575 - EN - EUR-Lex The EC implementing regulation is aimed at making changes within the current MDR/IVDR framework, to reduce administrative burden and streamline the process…
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January 12, 2026 in European Commission Updates Regulatory Affairs Newsletter, European Commission Updates Regulatory Affairs Newsletter Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive
Health Technology Assessment: New Opportunity to Apply for Joint Scientific Consultations
Please see the below information regarding EU joint Health Technology Assessment, with particular focus on joint Pharma, MD/IVD scientific advice meetings, for joint clinical assessments. Health Technology Assessment: New Opportunity to Apply for Joint Scientific Consultations Today, the Commission has opened theĀ first submission period for joint scientific consultations (JSCs) for 2026. This is the third submission periodĀ under the EU Health…
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