Regulatory Affairs

IVDR Extension: What Does This Mean for You?

The IVDR transition timelines have been extended, but that does not mean manufacturers can put compliance on hold.

Discover what Regulation (EU) 2024/1860 means for your IVD portfolio, which requirements and deadlines you need to consider, and how to use the additional time effectively.

Prepare your transition strategy and stay on track towards IVDR compliance.

About This White Paper

Regulation (EU) 2024/1860 introduced extended transitional periods for certain IVDs, giving manufacturers additional time to transition from the IVDD to the IVDR. However, benefiting from these extensions requires manufacturers to meet specific conditions and milestones, including an IVDR-compliant QMS and timely engagement with a Notified Body.

This white paper explains what the amended timelines mean in practice and why the extension should be viewed as an opportunity to accelerate, rather than postpone, IVDR readiness. It explores the key areas manufacturers need to address, from technical documentation and clinical evidence to PMS, PMPF and Quality Management Systems.

You will also discover practical strategies for identifying compliance gaps, prioritizing your portfolio and building a structured transition plan towards IVDR compliance.

Key Takeaways

✓ Understand the Extended IVDR Transition Timelines. Get a clear overview of the amended transitional provisions under Regulation (EU) 2024/1860, including the different milestones for Class D, Class C and Class B/Class A sterile IVDs.

✓ Know the Conditions Behind the Extension. Understand the prerequisites manufacturers must meet to benefit from the extended transition periods, including continued IVDD compliance, restrictions on significant changes and the requirement for an IVDR-compliant QMS.

✓ Turn Extra Time Into an IVDR Transition Strategy. Learn why postponing your compliance efforts can create regulatory bottlenecks, resource constraints and challenges with Notified Body capacity, and why manufacturers should keep their transition moving.

✓ Build IVDR-Compliant Technical Documentation. Discover why the new application deadlines should effectively be treated as deadlines for having your technical documentation ready, and how gap assessments, remediation plans and submission strategies can help you prepare.

✓ Strengthen Your PMS and PMPF Approach. Explore how robust post-market surveillance and post-market performance follow-up processes help monitor real-world device performance, identify emerging risks and maintain compliance throughout the product lifecycle.

✓ Address Clinical Evidence Gaps Before They Become Roadblocks. Understand the importance of scientific validity, state-of-the-art evidence, performance evaluation and a clear link between performance data and benefit-risk evaluation under the IVDR.

✓ Align Your QMS With IVDR Requirements. Learn why ISO 13485 certification alone does not automatically mean your QMS is IVDR-compliant, and which additional regulatory processes need to be incorporated into your quality system.

✓ Create a Practical Roadmap Towards IVDR Compliance. See how regulatory strategy, gap assessment, portfolio prioritization, remediation, mock audits and technical documentation assessment can come together in a structured IVDR transition approach.

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