The In Vitro Diagnostic Regulation (IVDR Regulation) – formally known as Regulation (EU) 2017/746 – marks a significant overhaul in how in vitro diagnostic (IVD) devices are regulated within the European Union. Fully replacing the older IVDD framework, the IVDR came into effect on May 26, 2017, with a mandatory compliance deadline of May 26, 2022. For medical device manufacturers, understanding the scope and structure of this regulation is essential to maintaining EU market access.
One of the most notable changes is the risk-based classification system. Under IVDR, IVDs are now categorized into four risk classes: A (low risk), B, C, and D (high risk). This approach replaces the previous list-based method under IVDD and reflects the device’s intended purpose and potential risk to public health.
Another major shift is the increased involvement of Notified Bodies. With IVDR, around 80–90% of IVDs now require assessment by a Notified Body—far more than under the old directive. This change has placed considerable emphasis on the importance of compliance, performance, and safety evaluation.
The IVDR also introduces stringent requirements for technical documentation and IVDR Performance evaluation. As per Annex II, manufacturers must submit comprehensive data related to device design, manufacturing controls, and risk management. This documentation serves as the foundation for CE marking and market approval.
In addition, the regulation outlines 20 General Safety and Performance Requirements (GSPR), up from the 13 essential requirements under IVDD. These requirements focus on aspects such as analytical performance, clinical evidence, software validation, and labeling.
Understanding the IVDR transition timelines is also critical. While IVDR officially became enforceable in 2022, the European Commission granted staggered transition deadlines—extending up to December 31, 2027 or 2028—depending on the device class and manufacturer readiness. These extensions are conditional and require continued compliance with key IVDR principles.
IVDR Performance Evaluation Report
Under the IVDR (EU) 2017/746, the Performance Evaluation Report (PER) is a mandatory component of the technical documentation for most in vitro diagnostic (IVD) devices. The PER demonstrates that the device achieves its intended purpose by meeting three core pillars: scientific validity, analytical performance, and clinical performance. These elements must be clearly documented and supported by robust data, including literature review, study reports, and real-world clinical evidence.
Manufacturers are required to continuously update the PER as part of their Post-Market Performance Follow-up (PMPF) activities. Failure to present a complete and compliant PER can result in delayed CE marking or rejection by the Notified Body. At I3CGLOBAL, our regulatory experts assist manufacturers in designing a performance evaluation plan, collecting the right data, and compiling a high-quality PER that meets Annex XIII and other IVDR expectations—ensuring faster approvals and sustainable EU market access.
Special Instructions from I3CGLOBAL’s IVDR Consultants
- Start with a Gap Assessment: Before jumping into documentation, conduct a detailed gap assessment comparing your existing IVDD compliance to IVDR requirements. This will help prioritize updates and avoid redundant efforts
- Reclassify All Devices: Even legacy devices must be reclassified under the new IVDR risk-based system. Don’t assume your previous classification still applies—many Class A devices under IVDD now fall under Class B or C.
- Work with a Notified Body Early: With limited IVDR-designated Notified Bodies in the EU, early engagement is critical. Initiate dialogue before finalizing your technical documentation to align expectations.
- Don’t Underestimate Performance Evaluation: Clinical evidence is now mandatory for most IVDs. Include analytical performance, clinical performance, and scientific validity—each needs documented proof.
- Build a Post-Market Surveillance (PMS) Strategy: IVDR mandates a living PMS plan with continuous updates. Don’t just prepare it for the submission—ensure your team knows how to implement it long-term
- Use GSPR as Your Checklist: The 20 General Safety and Performance Requirements (Annex I) should be your audit checklist. Map every requirement to specific sections in your technical file
- Leverage Expert Templates and Tools: Don’t reinvent the wheel. Use proven templates for Performance Evaluation Reports, Risk Management, and GSPR checklists to reduce approval time.
- Train Your Internal Team: IVDR is not just a regulatory project—it’s a quality and operational shift. Train RA, QA, R&D, and marketing teams to understand their roles in compliance
- Track Transition Timelines: Keep an eye on EU transition deadlines. Many manufacturers risk non-compliance due to incorrect assumptions about grace periods.
Notified Body Approach to Technical Documentation
Under the IVDR, Notified Bodies follow a stringent, risk-based review of technical documentation to ensure compliance with Annex II and III requirements. Their evaluation focuses on the device’s intended purpose, risk classification, performance evaluation, and compliance with General Safety and Performance Requirements (GSPR). They thoroughly assess clinical evidence, risk management files, labeling, and manufacturing controls. For Class B, C, and D IVDs, the technical file must be complete and well-structured. Any gaps or inconsistencies may trigger additional rounds of questions or outright rejection. A proactive, consultant-led submission significantly improves acceptance and approval timelines.
Notified Body IVDR File Review Timeline
Under the IVDR framework, the review of technical documentation by a Notified Body is a detailed, multi-phase process that can take 6 to 12 months, depending on the device classification, file quality, and Notified Body capacity.
For Class B and C IVDs, the process generally involves:
- Initial Application Review, Completeness Check and formal acceptance (4-6 weeks)
- In-depth Technical File Review (8–16 weeks or longer)
- Queries & Response Rounds (variable; each round takes 8-12 weeks)
- Final Assessment, Onsite Inspection & Certification Decision (4–8 weeks)
For Class D IVDs, expect a longer process, including additional scrutiny and expert panel consultation, which can add several months. Due to the limited number of IVDR-designated Notified Bodies and a high volume of applications, early planning and submission of a well-prepared technical file is essential to avoid delays and missed market entry timelines.
Conclusion: Why Choose I3CGLOBAL for IVDR Compliance?
Navigating the complex landscape of IVDR compliance requires more than just documentation—it demands strategy, expertise, and foresight. At I3CGLOBAL, IVDR consultants bring decades of experience supporting global IVD manufacturers through EU regulatory transitions. From precise gap assessments and accurate device classification to hands-on Notified Body coordination and performance evaluation support, our team simplifies every step of the IVDR journey. We offer validated templates, expert training, and post-market strategies tailored to your device and business model. With regulatory timelines tightening and risks of non-compliance growing, partnering with I3CGLOBAL ensures you remain competitive, compliant, and confidently positioned in the European market.