Navigating the IVDR Transition: Key Regulatory Updates

In light of recent amendments to the EU MDR and IVDR, the landscape of in vitro diagnostic medical devices (IVDs) is evolving to address critical concerns surrounding supply continuity and transitional arrangements.

Reasons for Regulatory Change

The transition to the In Vitro Diagnostic Regulation (IVDR), effective since May 26, 2022, marks a significant shift from the IVD Directive 98/79/EC, imposing heightened regulatory standards on all devices, including legacy products. The decision to extend transitional arrangements stemmed from challenges exacerbated by the Covid-19 pandemic, including infrastructure disruptions, limited availability of Notified Bodies, and delays in manufacturing readiness.

Updated Compliance Deadlines

Recent amendments have extended compliance deadlines based on device risk classification:

• Class D (Highest Risk): Deadline extended to December 31, 2027
• Class C: Deadline extended to December 31, 2028
• Class B, Class A Sterile: Deadline extended to December 31, 2029

Manufacturers seeking to benefit from these extensions must adhere to specific conditions, including maintaining CE marking under the IVD Directive, implementing a Quality Management System compliant with IVDR by May 26, 2026, and notifying a relevant notified body well in advance of the revised deadlines.

Accelerated Eudamed Adoption

The amendments also accelerate the mandatory adoption of the Eudamed database, a pivotal component of IVDR deployment, by advancing the utilisation of key Eudamed modules.

What's the impact?

These regulatory updates provide crucial breathing room for Class D device manufacturers, who face unique challenges due to their low-volume, high-stakes nature. The emphasis on increased Eudamed usage underscores the importance of comprehensive regulatory oversight during the transition.

Action Required

Manufacturers are urged not to delay in finalising technical documentation, engaging with notified bodies, and ensuring full readiness for IVDR compliance. At PeploBio, our regulatory experts stand ready to support your organisation through these transitions. Contact our team to discuss your specific needs and navigate the evolving regulatory landscape confidently.

‍