Three lessons learned from EU MDR implementation to ensure IVDR adoption

In the previous article, “How The Right Operating Model For EU MDR Compliance Can Support A Global Footprint,” we discussed key factors for maintaining operational excellence to achieve cost reduction, enhanced compliance, and support global footprint. In this article, we shift our focus toward leveraging lessons learned from EU MDR implementation to ensure seamless transition during IVDR implementation, thereby minimizing the risks of product disruption in the EU market.

The new IVDR requirements present significant challenges for manufacturers, with approximately 90% of all IVD products subject to notified body (NB) review, which is a substantial increase from the current rate of less than 15%. With the limited capacity of NBs, establishing relationships with NBs and engaging in early planning are crucial. These amplify concerns over experience gaps for companies without a quality management system (QMS) for IVDs or any device products, established process and documentation system, or limited experience interacting with NBs. Bridging these gaps and establishing sustainable processes pose additional burdens for IVD manufacturers. However, drawing from EU MDR implementation lessons, IVD manufacturers can navigate this transition, mitigate risks, minimize business disruption, and ensure a smooth transition to IVDR.

For IVD manufacturers, the key lessons learned that can be leveraged from EU MDR implementation include early QMS preparation and planning and collaboration with internal and external stakeholders for project alignment and resource planning, alongside digitalization efforts to support data management and documentation.

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