In Vitro Diagnostic Regulation: Expert Guide to EU 2017/746
A brief guide to IVDR (EU) 2017/746 compliance, including risk-based classification, technical documentation requirements, and conformity assessment.
The In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746 has reshaped the European diagnostics landscape more comprehensively than any previous regulatory change. As of 2025, the IVDR framework is fully in force, supported by extended transition timelines introduced by Regulation (EU) 2023/607, a steadily expanding EUDAMED infrastructure, and maturing notified-body capacity. The regulation sets stringent expectations around technical documentation, performance evidence, UDI traceability, post-market surveillance, and quality management systems, transforming how manufacturers design, validate, and maintain diagnostic products for the European market.
The Shift from IVDD to IVDR
The transition from the In Vitro Diagnostic Devices Directive (IVDD 98/79/EC) to the IVDR marks one of the most significant regulatory overhauls in the EU medical technology sector. Under the former IVDD, the majority of In Vitro Diagnostic Regulation around 80 percent were self-declared, resulting in limited oversight and light evidence expectations. IVDR reverses this with a comprehensive risk-based system that requires notified-body involvement for the majority of devices and introduces robust performance evaluation, lifecycle documentation, and post-market obligations. This move reflects the EU's broader effort to modernise regulatory systems, improve public health protection, and align diagnostics with the increasing complexity of digital and genetic technologies paralleling the shift also seen with the EU AI Act for high-risk AI systems.
IVDR Objectives and Regulatory Scope
IVDR's overarching aim is to strengthen patient protection and market transparency through harmonised, evidence-driven regulatory rules. The regulation covers the entire lifecycle of an in vitro diagnostic device, beginning from design and development and extending through conformity assessment, clinical and analytical performance evaluation, manufacturing controls, post-market surveillance, and end-of-life decommissioning. The scope is broad and inclusive. It applies to traditional assays, reagent kits, companion diagnostics, genetic risk scores, infectious disease tests, and also modern categories such as machine-learning-based software that drives diagnostic output or contributes diagnostic information. Laboratory-developed tests (LDTs) fall within the legal framework for the first time, with transitional arrangements extending into 2028–2030 depending on risk and availability of CE-marked alternatives.
Risk-Based Classification
Classification under the IVDR follows a four-tier system (A, B, C, D) defined in Annex VIII, based on both individual and public health risk. This classification model is central to determining conformity assessment requirements, evidence thresholds, and notified-body involvement.
MDCG guidance documents such as MDCG 2020-16 Rev.1, MDCG 2022-2, and MDCG 2023-3 continue to clarify classification rules, especially for borderline products and software.
Conformity Assessment Pathways in 2025
The conformity assessment process varies by class, but in every case the In Vitro Diagnostic Regulation requires a structured demonstration of safety, performance, and regulatory compliance. Class A non-sterile devices remain the only group eligible for pure self-declaration. All other devices require notified-body involvement to some degree, and Class D devices must undergo the most comprehensive scrutiny, including consultation with EU Reference Laboratories (EURLs) for batch verification and technical review. As of 2025, more than a dozen notified bodies have been designated under IVDR. Although capacity has improved compared to 2022, demand continues to exceed supply, which makes early engagement and strategic planning crucial to avoid delays.
Technical Documentation Expectations
Technical documentation under the IVDR is significantly deeper and more structured than under the IVDD. Manufacturers must produce, maintain, and keep available a complete set of documents that demonstrate compliance with Annex II and III. This includes a clear device description and intended purpose, risk management documentation aligned with ISO 14971, detailed design and manufacturing information, analytical and clinical performance data, stability studies, PMS and PMPF plans, UDI assignment records, cybersecurity documentation, and the overall quality management system according to ISO 13485. For software-based diagnostics, the documentation must also include software lifecycle evidence consistent with IEC 62304, cybersecurity risk assessments following EN 82304-1 and MDCG 2019-16, and detailed records of algorithm behaviour, validation, update processes, and where relevant AI explainability.
Performance Evaluation Requirements
Performance evaluation under the IVDR is structured around a three-pillar model, and each pillar must be supported by robust, methodologically sound evidence:
- Scientific Validity – demonstrating that the analyte or biomarker has a well-established biological and clinical association with the condition being assessed. This evidence typically draws on peer-reviewed literature, consensus guidelines, and recognised scientific sources.
- Analytical Performance – establishing that the test reliably measures the analyte with acceptable accuracy, precision, specificity, interference controls, detection limits, and other key analytical parameters.
- Clinical Performance – confirming that the device delivers clinically meaningful results in real-world conditions, including validated sensitivity, specificity, and predictive values relevant to the intended patient population.
Together, these three pillars form the core of the Performance Evaluation Report (PER). Under the IVDR, this is not a one-time exercise: manufacturers must continuously update scientific, analytical, and clinical evidence through Post-Market Performance Follow-Up (PMPF), ensuring that ongoing data from routine use feeds directly into risk management, design updates, and lifecycle controls. MDCG guidelines including MDCG 2022-9 and MDCG 2022-10 provide practical direction for assembling compliant and comprehensive PER documentation.
Post-Market Surveillance and Vigilance
The IVDR imposes a proactive, continuous model of post-market surveillance (PMS). Manufacturers must monitor device performance in real-world settings, identify emerging trends, mitigate potential risks, and document all corrective actions. Serious incidents and field safety corrective actions must be reported through vigilance systems, which will eventually be fully integrated into EUDAMED once all modules are audited and functional. By 2025, several EUDAMED modules including actor registration, UDI/device registration, notified-body certificates, vigilance, and clinical investigation are operational on a voluntary basis. Full mandatory use is expected to begin once the final missing modules become functional, currently projected for 2026.
UDI and Supply-Chain Traceability
The UDI system is now a central pillar of device traceability. Every IVD must carry a UDI-DI and UDI-PI, and manufacturers must upload relevant information into EUDAMED. This supports a more transparent supply chain, efficient recall processes, and improved public health surveillance. MDCG 2021-19 provides guidance for implementation and labelling considerations.
Companion Diagnostics (CDx)
Companion diagnostics have undergone substantial regulatory elevation under the IVDR, moving into Class C and requiring joint consultation between the notified body and the EMA or national competent authorities. These consultations focus on the scientific rationale behind the test–medicine relationship and ensure that performance claims are aligned with clinical data from the medicinal product. This dual-review model has made timelines longer and documentation requirements more rigorous, particularly for oncology biomarkers, pharmacogenomic assays, and precision-medicine applications.
Software and AI-Based Diagnostics
Software that processes biological information or contributes diagnostic interpretation is explicitly covered by IVDR and frequently falls into Class C or D depending on its intended medical purpose. By 2025, software-based IVDs increasingly incorporate machine-learning or AI techniques, which introduces parallel obligations under the EU AI Act 2024/2025 for high-risk AI systems. Software manufacturers must document their algorithms in detail, demonstrate explainability where applicable, validate performance using representative datasets, and show robust controls for software updates, cybersecurity, and version management. Ongoing performance monitoring is critical, especially for adaptive or continuously learning algorithms, which must be placed in a controlled change-management regime under both IVDR and the AI Act.
Laboratory-Developed Tests (LDTs)
For the first time, LDTs are explicitly addressed under the IVDR. Clinical laboratories may continue to use LDTs under strict conditions: the tests must be produced and used within the same health institution, must meet essential safety and performance requirements, and must only be used when no equivalent CE-marked device exists. The 2023/607 amendment extended transitional timelines for LDTs into 2028–2030, recognising the complexity and resource constraints faced by many laboratories. Nevertheless, labs are required to upgrade their quality systems (typically to ISO 15189), document validations thoroughly, and prepare for eventual compliance.
2025 Transition Timelines (Regulation 2023/607)
The In Vitro Diagnostic Regulation introduces staggered deadlines that reflect both risk and notified-body capacity considerations. Class D devices are expected to transition by 31 December 2027, while Class C devices have until the end of 2028. Class B and Class A sterile devices follow in 2029. LDTs benefit from extended timelines, but only if several conditions are met, including the absence of equivalent CE-marked alternatives and the presence of an appropriate quality management system within the clinical laboratory.
Strategic Challenges and Industry Responses
The IVDR's scope and depth have introduced several challenges for manufacturers, particularly around documentation volume, clinical evidence requirements, software validation, and notified-body engagement. Notified-body bottlenecks continue to require early planning, and many companies have had to restructure product portfolios, prioritising submissions that are commercially strategic or clinically necessary. Performance evaluation remains one of the most time-intensive components due to the need for robust datasets, and software manufacturers continue to adapt to the dual expectations of medical-device and AI-risk governance. Despite these challenges, companies that invest early in compliant design, structured evidence strategies, and high-quality documentation find themselves better positioned for smoother conformity assessment and long-term competitiveness. Strong quality management systems and clear regulatory intelligence functions are increasingly seen as differentiators in an evolving diagnostics market.
How Nemko Digital Supports IVDR Compliance
Nemko Digital provides comprehensive regulatory support to help manufacturers navigate the evolving IVDR landscape. Our services include classification assessments, gap analyses, technical-documentation development, performance-evaluation planning, ISO 13485 and ISO 14971 aligned QMS implementation, laboratory compliance for LDTs, software and AI diagnostic validation, and assistance with UDI and EUDAMED readiness. Our cross-functional expertise in diagnostics, AI governance, and global regulatory intelligence allows us to guide organisations through notified-body interactions and ensure that compliance strategies remain sustainable, efficient, and aligned with the latest EU expectations.
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