Upgrading QMS to IVDR Requirements

Under the IVDR (EU 2017/746), all IVD manufacturers must implement a Quality Management System (QMS) that complies with Article 10(8) and Annex IX of the Regulation. This requirement applies even to companies that previously marketed their devices under self-declaration routes of the IVDD.

Upgrading your QMS means aligning every process from product design to post-market activities with IVDR specific expectations. It’s not just about ISO 13485 certification; it’s about embedding IVDR-specific elements that ensure continuous compliance and traceability throughout the device lifecycle.

Key QMS elements to address include:

1. Performance Evaluation System: Your QMS must integrate a structured, documented process for performance evaluation covering scientific validity, analytical performance, and clinical performance. This ensures that the device consistently achieves its intended purpose under real world conditions.

2. Post-Market Surveillance and Post-Market Performance Follow-up: Manufacturers must maintain a proactive and continuous PMS system to collect, analyze, and react to data on device performance and safety. PMPF, as part of PMS, verifies ongoing device performance and identifies potential improvements or risks over time.

3. Risk Management Procedures: IVDR mandates a living risk management system in line with ISO 14971. This system must cover risk analysis, evaluation, control, and monitoring throughout the device’s lifetime, linking directly to performance evaluation and PMS data.

4. Technical Documentation and Traceability: All QMS processes must ensure traceability between design, verification, validation, and post-market activities. This documentation becomes the foundation for Notified Body review during IVDR conformity assessment.

5. Supplier and Subcontractor Controls: Under IVDR, manufacturers are responsible for ensuring that suppliers and subcontractors comply with applicable regulatory requirements. This involves enhanced qualification, auditing, and documentation of critical suppliers.

Under EU IVDR Article 10(8), the manufacturer must establish, document, implement, and maintain a Quality Management System (QMS) appropriate to their devices by May 26, 2025. This means the QMS must be fully operational and covering all relevant processes, not merely documented or planned. However, this requirement does not explicitly mandate that the QMS must be certified by a Notified Body by that date, meaning it must be implemented and functional but formal certification or NB audit can come later as part of the conformity assessment.

In practice, the QMS documentation must be ready and the system operational to demonstrate compliance, which supports the manufacturer’s ability to benefit from the IVDR transitional provisions. Certification by a Notified Body (NB) through audits is still necessary for Class B devices, but the May 26, 2025 deadline focuses on implementation rather than certification completion.