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European Commission Updates Regulatory Affairs Newsletter

European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Team NB – Position paper on the demonstration of safety and performance for combinational Use of Reagent Devices with other Equipment

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
Ben Kemp
March 2, 2026
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveIndustry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory 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 €150.00 View article...
Ben Kemp
February 20, 2026
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory 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 • 1st đź“Ł 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…
Ben Kemp
February 6, 2026
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory 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 – 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…
Ben Kemp
January 12, 2026
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory 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 the first submission period for joint scientific consultations (JSCs) for 2026. This is the third submission period under the EU Health…
Ben Kemp
January 12, 2026
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

CELEX:32025L2647: Directive (EU) 2025/2647 of the European Parliament and of the Council of 16 December 2025 amending Directive 2013/11/EU on alternative dispute resolution for consumer disputes and amending Directives (EU) 2015/2302, (EU) 2019/2161 a

Dear Members, please see below updated EU legislation regarding Consumer Protection and dispute resolution. This impacts Business to Consumer transactions e.g for self-test devices, and includes digital products and services. Directive (EU) 2025/2647 of the European Parliament and of the Council of 16 December 2025 amending Directive 2013/11/EU on alternative dispute resolution for consumer disputes and amending Directives (EU) 2015/2302,…
Ben Kemp
January 12, 2026
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

CELEX:32025R2605: Council Regulation (EU) 2025/2605 of 12 December 2025 amending Regulation (EU) 2021/2278 suspending the Common Customs Tariff duties referred to in Article 56(2), point (c), of Regulation (EU) No 952/2013 of the European Parliament

Dear members, please note that the EU has updated it’s list of common customs tariffs which have been suspended for imports into the EU. This includes chemicals and components used in electronics etc. Council Regulation (EU) 2025/2605 of 12 December 2025 amending Regulation (EU) 2021/2278 suspending the Common Customs Tariff duties referred to in Article 56(2), point (c), of Regulation…
Ben Kemp
January 12, 2026
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

CELEX:32025R2645: Regulation (EU) 2025/2645 of the European Parliament and of the Council of 16 December 2025 on compulsory licensing for crisis management and amending Regulation (EC) No 816/2006 (Text with EEA relevance)

Dear members, for your information. New EU legislation that allows the ability for compulsory licensing of Intellectual property during a crisis. Regulation (EU) 2025/2645 of the European Parliament and of the Council of 16 December 2025 on compulsory licensing for crisis management and amending Regulation (EC) No 816/2006 (Text with EEA relevance) View article...
Ben Kemp
January 12, 2026
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

EU IVDR MDCG 2025-10 – Guidance Document on post-market surveillance of medical devices and in vitro diagnostic medical devices

Dear members, please see new Guidance Document on post-market surveillance of medical devices and in vitro diagnostic medical devices MDCG 2025-10. The guidance was developed in co-operation with the MedTech Europe PMS and Vigilance Working group. The European Commission has recently published a new Guidance Document on post-market surveillance of medical devices and in vitro diagnostic medical devices (MDCG 2025–10).…
Ben Kemp
January 12, 2026
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