Insight: Navigating the EU In Vitro Diagnostic Regulation (IVDR)
Published: September 2025
A New Era for In Vitro Diagnostics in Europe
The EU In Vitro Diagnostic Regulation (IVDR) – formally Regulation (EU) 2017/746 – has reshaped the regulatory environment for diagnostic devices across Europe. Replacing the outdated In Vitro Diagnostic Medical Devices Directive (IVDD 98/79/EC), the IVDR establishes a modern, risk-based framework to strengthen patient safety, device performance, and transparency.
For manufacturers worldwide, the EU IVDR is not simply another regulation. It represents a fundamental change in how Europe governs diagnostic tools, demanding a new level of preparedness and long-term compliance strategy.
What Is the EU IVDR?
Since its complete application on 26 May 2022, the IVDR has introduced stricter requirements that affect every stage of the IVD lifecycle. Its core innovations include:
- Risk-based classification: Devices are grouped into four new risk classes (A–D), ensuring regulatory scrutiny aligns with potential risk to patients and public health.
- Greater Notified Body involvement: Whereas under IVDD only 15% of devices required review, under IVDR, 80–90% now need third-party assessment.
- Stricter clinical evidence: Manufacturers must provide robust performance data demonstrating scientific validity, analytical reliability, and clinical relevance.
- Post-market surveillance: Ongoing monitoring and performance follow-up are now mandatory for most IVDs.
- Economic operator obligations: Manufacturers, importers, distributors, and Authorised Representatives each carry clearly defined responsibilities.
Transparency is also reinforced through EUDAMED, the European database where key information about IVDs will be publicly available to healthcare professionals, patients, and regulators.
Who Is Affected by the Regulation?
The IVDR impacts the entire IVD supply chain:
- Manufacturers – must classify products correctly, compile comprehensive technical documentation, and establish strong post-market systems. Non-EU manufacturers must appoint an EU Authorised Representative.
- Authorised Representatives – no longer administrative contacts but active compliance partners, verifying documentation, monitoring obligations, and acting as EU liaison.
- Importers – must ensure CE marking, correct labelling, Declarations of Conformity, and cooperate with authorities when non-conformities arise.
- Distributors – responsible for checking product compliance before placing IVDs on the market and reporting user complaints.
- Notified Bodies – now central players in conformity assessment, though limited availability has created certification bottlenecks—especially for high-risk Class D devices.
Risk-Based Classification: Four New Classes
The IVDR replaces the old list-based approach with a risk-based system:
- Class A – Low risk (e.g., specimen receptacles)
- Class B – Moderate risk (e.g., fertility tests)
- Class C – High individual risk or moderate public risk (e.g., cancer diagnostics, self-tests)
- Class D – High individual and public risk (e.g., HIV and hepatitis testing, transfusion blood grouping)
This system directly influences the depth of technical documentation and the level of Notified Body oversight required.
Performance Evaluation and Clinical Evidence
The IVDR demands robust performance evaluation supported by three pillars:
- Scientific validity – Demonstrating that the biomarker or analyte is clinically relevant.
- Analytical performance – Proving accuracy, sensitivity, specificity, and reproducibility.
- Clinical performance – Showing that the device delivers reliable results in its intended clinical use.
These are captured in the Performance Evaluation Plan (PEP) and Performance Evaluation Report (PER). In addition, Post-Market Performance Follow-Up (PMPF) ensures that real-world performance continues to meet expectations.
Why It Matters
The EU IVDR is not just a compliance exercise—it is a complete redefinition of market access. Companies must rethink their documentation, testing, and surveillance strategies while navigating a more complex relationship with Notified Bodies and regulators.
Ultimately, the IVDR is designed to improve patient protection, raise diagnostic standards, and foster trust. But for manufacturers, it represents a significant operational and regulatory challenge.
How QNET Supports Global Manufacturers
At QNET, we know that compliance with the EU IVDR is both complex and business-critical. With decades of experience supporting manufacturers across the EU, UK, Switzerland, and the US, we provide tailored services as your EU Authorised Representative:
- Verification of technical documentation and Declarations of Conformity
- Guidance on classification strategy and conformity assessment routes
- Support with performance evaluation requirements (PEP, PER, PMPF)
- Oversight of post-market surveillance and vigilance reporting
- Acting as your trusted liaison with EU authorities and Notified Bodies
Our in-house Person Responsible for Regulatory Compliance (PRRC) ensures that your documentation and processes meet the highest standards set by the EU IVDR.
With QNET as your partner, you gain more than EU market access. You gain peace of mind that your IVD products are compliant, monitored, and trusted throughout their lifecycle.
Key Takeaways for Manufacturers and Stakeholders
- Most IVDs now require Notified Body involvement.
- Non-EU manufacturers must appoint an EU Authorised Representative.
- Clinical evidence and performance evaluation are central to compliance.
- Post-market obligations are ongoing, not one-time requirements. Transitioning to IVDR compliance requires not just technical updates but a strategic foresight.