Stay current on regulatory changes affecting pharma, medical devices, and IVD — expert analysis of new guidelines and legislation.
ISO 14155:2026, the fourth edition of the international Good Clinical Practice standard for medical device clinical investigations, has been published. It replaces ISO 14155:2020 and sets new requirements for risk management, Clinical Events Committees, Data Monitoring Committees, study design and adverse event reporting.
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ICH E2D(R1) introduces new expectations for ODCS, PSPs, MRPs and digital platforms. Learn what MAHs must implement by 18 March 2026 to ensure pharmacovigilance compliance.
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The European Medicines Agency (EMA) has adopted a Reflection Paper on the Qualification of Non-Mutagenic Impurities (EMA/CHMP/4299/2026), introducing a new scientific framework for the safety assessment of non-mutagenic impurities in medicinal products.
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On 16 December 2025, the European Commission published a Proposal for a Regulation of the European Parliament and of the Council amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards simplifying and reducing the burden of the rules on medical devices and in vitro diagnostic medical devices, with the stated aim of simplifying and reducing regulatory burden for medical devices and in vitro diagnostic medical devices, while maintaining a high level of public health protection.
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On 15 December 2025, the UK Medicines and Healthcare products Regulatory Agency (MHRA) has published a new IVD Roadmap, setting out the planned priorities and deliverables for its IVD regulatory programme through mid-2027. This roadmap complements the existing Medical Devices Regulatory Reform Roadmap and provides insight into MHRA’s priorities for the coming years.
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On 15 December 2025, the Medical Device Coordination Group (MDCG) published MDCG 2025-9 - Guidance on Breakthrough Devices (BtX) under Regulations 2017/745 & 2017/746, introducing a streamlined regulatory pathway for Breakthrough Devices (BtX) under the MDR and IVDR. The guidance establishes a formal designation process for highly novel devices with a significant positive clinical impact, enabling accelerated conformity assessment and early market access supported by robust post-market evidence generation.
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On December 12th 2025 the European Commission has released for consultation the draft Implementing Regulation (EU 2025) laying down certain uniform quality management and procedural requirements for the conformity assessment activities carried out by a notified body designated under Regulations (EU) 2017/745 and (EU) 2017/746 of the European Parliament and of the Council.
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On 01/12/2025, the European Medicines Agency (EMA) released an update to Appendix 1 (EMA/42261/2025/Rev. 11) of the Nitrosamines Guideline. This appendix lists nitrosamines for which an established Acceptable Intake (AI) is available.
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On 27 November 2025, the Commission Decision (EU) 2025/2371 of 26 November 2025 on the notice regarding the functionality and the fulfilment of the functional specifications of certain electronic systems included in the European Database on Medical Devices was published in the Official Journal of the EU (OJEU), confirming that four EUDAMED modules are fully operational.
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On November 10th, 2025, the EU Member States and the European Commission opened a new call for sponsors to join the pilot coordinated assessment of clinical investigations under Regulation (EU) 2017/745 (MDR) and performance studies under Regulation (EU) 2017/746 (IVDR).
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On October 22nd Team-NB published two new Position Papers. One addresses changes to companion diagnostic devices under the IVDR, Annex IX, section 5.2 that require prior approval by a notified body while the other is a template agreement related to the transfer of MDR formal application and of appropriate surveillance of legacy devices.
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The European Commission has published the final version of the new Variations Guidelines for human medicines, which will take effect on 15 January 2026 and are designed to support the new Variations Regulation that entered into force in January 2025.
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On 3 September 2025, the Team-NB published a revised version of their position paper on Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746. The revision includes updates to various sections and brings the content up-to-date. Additionally, clarification in wording and improved formatting is included.
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