The European Commission officially published 54 detailed Questions & Answers (Q&A) addressing the In Vitro Diagnostic Medical Devices Regulation (IVDR) Performance Studies on June 18, 2025. This pivotal document, MDCG 2025-5, aims to clarify complex aspects of IVDR, providing essential guidance for manufacturers and regulatory bodies navigating the compliance landscape.
Key Highlights of the IVDR Q&A
Among the 54 questions, significant attention is given to ethical review processes and specimen handling across member states. The guidance emphasizes the necessity for entities to verify national requirements concerning ethics committee submissions and ensure all parties have access to the latest documentation versions. Notably, the document does not establish a centralized Ethics Review Board within the EU, reflecting the diverse regulatory frameworks of its 27 member states.
Impact on Industry Practices
The introduction of Figures and Appendices in MDCG 2025-5 serves as practical tools for stakeholders. Figure 2 elucidates the relationship between various performance study articles, while Appendix 1 offers a flow diagram to determine reporting requirements. These resources streamline the decision-making process for categorizing studies as applications, notifications, or non-performance studies, thereby enhancing regulatory compliance and efficiency.
- Clarifies ethical review requirements across different EU member states.
- Provides visual aids like Figure 2 and Appendices to simplify compliance procedures.
- Defines key terms such as “surgically invasive sample-taking” and “leftover samples” for consistent application.
- Addresses companion diagnostics, distinguishing them as interventional clinical performance studies.
- Anticipates future coordinated assessments and integration with medicinal product studies.
Performance studies hold significant weight in the regulatory strategies of introducing novel or high-risk In Vitro Diagnostics (IVD) to the European market. The comprehensive nature of MDCG 2025-5 addresses previously ambiguous areas, reducing the uncertainty for manufacturers. By clearly outlining the requirements and procedures, the guidance fosters a more predictable and streamlined pathway for IVD approvals, ultimately benefiting both developers and end-users through enhanced product safety and efficacy.
Stakeholders are encouraged to utilize the provided figures and appendices to navigate the complexities of IVDR compliance effectively. Manufacturers should pay particular attention to the definitions and examples offered, ensuring that all performance studies are categorized correctly and meet the stipulated regulatory standards. This proactive approach not only facilitates smoother regulatory submissions but also reinforces the integrity and reliability of medical diagnostics within the EU market.
As the regulatory landscape continues to evolve, ongoing updates and pilot programs, such as the coordinated assessment of performance studies, are expected to further refine and improve the IVDR framework. Engaging with these developments and leveraging the comprehensive guidance provided will be crucial for maintaining compliance and fostering innovation in the medical device sector.
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