Introduction
With the implementation of Regulation (EU) 2024/1860, the requirements and timelines for in vitro diagnostic medical devices (IVDs) under the In Vitro Diagnostic Regulation (IVDR) 2017/746 have been updated. These changes address the practical challenges of compliance and ensure that essential IVDs remain available in the European market. We outline the specific areas notified bodies will assess, highlighting the updated deadlines and procedural requirements from Regulation 2024/1860.
Key Areas of Focus for Notified Body Assessments under Regulation (EU) 2024/1860
1. Quality Management System (QMS)
Regulation Impact: According to Regulation 2024/1860, manufacturers using the extended compliance deadlines must implement a QMS in line with IVDR Article 10 by May 26, 2025. Notified bodies will assess the QMS to ensure it meets IVDR requirements.
- Implementation and Maintenance: Your QMS must be comprehensive and continuously maintained to align with IVDR standards, covering all stages of the device lifecycle.
- Process Controls: Notified bodies will examine how you manage design, production, and post-market processes to verify that they meet regulatory standards.
- Documentation: Detailed documentation is essential to demonstrate traceability and compliance, a requirement underscored by the extended deadlines in Regulation 2024/1860.
2. Technical Documentation
Regulation Impact: The transitional periods extended by Regulation 2024/1860 allow more time for compliance but require manufacturers to keep their technical documentation up to date with IVDD standards until the new deadlines.
- Device Description and Specifications: Include the intended purpose, risk classification, and design specifications to ensure compliance and avoid delays.
- Performance Evaluation: Data confirming your device's analytical and clinical performance will be required for notified body review, especially as compliance deadlines approach.
- Risk Management: Regulation 2024/1860 requires comprehensive risk documentation in line with IVDR standards, demonstrating your ability to identify and address potential risks.
- Labeling and Instructions for Use: Labels and instructions must meet IVDR clarity, accuracy, and safety standards, which notified bodies will evaluate to ensure proper use.
3. Post-Market Surveillance (PMS)
Regulation Impact: The extended deadlines grant time to finalize PMS procedures, but these must still align with IVDR's strict post-market monitoring requirements.
- PMS Plan: A proactive PMS plan is essential for ongoing safety and effectiveness monitoring, as the IVDR specifies.
- Periodic Safety Update Reports (PSUR): Regular updates on safety data are required to maintain compliance during the transitional period.
- Vigilance System: Notified bodies will evaluate your system for managing and reporting incidents as part of your ongoing compliance obligations under IVDR and Regulation 2024/1860.
4. Clinical Evidence
Regulation Impact: Despite transitional extensions, clinical evidence requirements remain unchanged. These must meet IVDR standards, proving the device's performance, scientific validity, and analytical reliability.
- Clinical Performance Studies: Data from real-world studies is required to show the device performs safely and effectively.
- Scientific Validity: Evidence for the scientific basis of the device's analyte is critical for compliance.
- Analytical Performance: Notified bodies will assess that your device reliably measures as intended, supporting both IVDR and transitional compliance under Regulation 2024/1860.
5. Regulatory Compliance
Regulation Impact: Regulation 2024/1860 mandates that manufacturers follow the appropriate IVDR conformity assessment routes, depending on the device classification, even within extended timelines.
- Conformity Assessment Procedures: The required assessment route will depend on your device's risk class, which impacts compliance timelines.
- Declarations of Conformity: These formal declarations confirm your device meets IVDR standards, an ongoing requirement even with deadline extensions.
- Unique Device Identification (UDI): Implementing UDI systems remains mandatory, improving traceability as required by IVDR and Regulation 2024/1860.
6. Supplier and Subcontractor Controls
Regulation Impact: Supplier and subcontractor management is crucial, especially for devices under extended deadlines. Compliance with quality agreements and regular audits is necessary to meet both IVDD and IVDR standards during the transitional period.
- Qualification and Monitoring: Selection, qualification, and regular monitoring of suppliers must meet IVDR standards.
- Formal Agreements: Agreements must outline clear quality and compliance requirements, with records of audits as evidence.
- Audit Records: Regular supplier audits ensure compliance continuity, meeting IVDR standards even through extended deadlines under Regulation 2024/1860.
7. Unannounced Audits
Regulation Impact: Notified bodies may conduct unannounced audits to verify ongoing compliance. Maintaining readiness for these audits is crucial, especially as the regulation emphasizes safety and reliability throughout the extended compliance period.
- Readiness: Since unannounced audits are a tool for verifying compliance, organizations should stay prepared to demonstrate compliance with IVDR and meet regulatory expectations under Regulation 2024/1860.
Conclusion
Regulation (EU) 2024/1860 introduces significant amendments that provide flexibility in IVDR compliance deadlines while maintaining strict requirements for safety and reliability. By focusing on these areas, your organization can position itself for successful compliance, meeting immediate IVDD and future IVDR requirements. Our team is here to guide you through each step, ensuring that your products continue to meet the standards for safety and effectiveness.
Don't hesitate to contact our team if you have questions or need support in preparing for notified body assessments. We're committed to helping you achieve successful, seamless compliance with IVDR and Regulation 2024/1860.