CE Marking
CE IVDR Regulatory Compliance
Performance evaluation and technical documentation under Regulation (EU) 2017/746 for in-vitro diagnostic devices.
Applies to: In-vitro diagnostic manufacturers
What Is IVDR and Why It Matters?
The EU IVDR (Regulation (EU) 2017/746) establishes strict regulatory requirements for in vitro diagnostic medical devices in the European Union. It significantly increases oversight compared to the previous directive, particularly in clinical evidence, and post-market surveillance. IVDR expands the role of notified bodies and requires more comprehensive technical documentation. Compliance is mandatory for CE marking of IVD products in the EU market. The regulation aims to enhance patient safety, product transparency, and diagnostic reliability.
How Can We Help?
IVDR has reshaped the IVD landscape — and many manufacturers underestimate its complexity. The expanded classification rules, performance evaluation requirements, and notified body involvement make compliance significantly more demanding than before. We conduct a structured gap assessment and develop a clear compliance strategy tailored to your product portfolio. Our team strengthens performance evaluation reports, restructures technical documentation, and aligns PMS and vigilance systems with IVDR expectations. By anticipating regulatory scrutiny and managing timelines proactively, we minimize risk, prevent costly delays, and guide you confidently toward successful CE marking under IVDR.
FAQ
EU IVDR — frequently asked questions
The EU Medical Device Regulation (MDR) applies to medical devices, while the EU In Vitro Diagnostic Regulation (IVDR) applies specifically to in vitro diagnostic devices.
Yes. Devices previously certified under MDD or IVDD must transition to MDR or IVDR within defined timelines. Many devices now require reclassification, additional clinical data, and updated technical documentation.
- Because they significantly increase: Clinical evidence requirements
- Regulatory scrutiny by Notified Bodies
- Documentation depth and traceability
- Post-market surveillance obligations
Many manufacturers face delays or market withdrawal due to underestimating these changes.
Timelines depend on device classification, technical complexity, and documentation readiness. For MDR and IVDR projects, the most time-consuming factors are clinical or performance evidence, technical documentation completeness, and Notified Body availability. Poor preparation is the main reason projects exceed planned timelines.
Costs vary widely and depend on:
- Device classification and scope
- Clinical or performance study needs
- Notified Body involvement and fees
- Internal readiness and documentation quality
Unplanned rework, rejected submissions, and late-stage redesigns are the largest cost drivers.
Certilance supports manufacturers with MDR/IVDR gap analysis, quality management system alignment, technical file structuring, and Notified Body audit preparation which reduce approval risk and time to market.
EU IVDR
Ready to start your EU IVDR project?
Book a free consultation and we will map the gaps, the timeline and the cost before any work begins.