EU IVDR In Vitro Diagnostic Regulation Consulting
Navigate the complex EU IVDR transition with confidence. From IVD classification and performance evaluation to Notified Body submissions, our experts ensure your in vitro diagnostic devices meet every regulatory requirement.
Four-Class Risk-Based IVD Classification
EU IVDR (2017/746) introduced a rule-based classification system replacing the IVDD list-based approach. Understanding your device class determines your entire regulatory pathway.
Class A
General laboratory instruments, specimen receptacles, buffer solutions, and wash solutions. Self-assessment permitted for non-sterile, non-measuring devices.
Class B
Default classification for IVDs not covered by other rules. Includes clinical chemistry analyzers, pregnancy self-tests, and antimicrobial susceptibility tests.
Class C
Blood typing (non-ABO/Rh), companion diagnostics, genetic testing, HLA typing, tumor markers, and prenatal screening for congenital conditions.
Class D
Blood screening for HIV, Hepatitis B/C, HTLV; blood grouping (ABO, Rh, Kell); transfusion-transmissible agents. Requires EU Reference Laboratory involvement.
Comprehensive IVDR Consulting Services
End-to-end regulatory support for IVD manufacturers navigating the EU IVDR landscape, from classification through post-market surveillance.
IVDR Classification & Strategy
Expert classification of your IVD devices under IVDR Annex VIII rules, with strategic regulatory pathway planning based on risk class determination.
IVDR Transition Planning
Comprehensive IVDD-to-IVDR transition roadmaps with timeline management ensuring you meet staggered deadlines extended by Regulation (EU) 2024/1860.
Performance Evaluation Studies
Design and execution of scientific validity, analytical performance, and clinical performance studies to meet IVDR evidence requirements.
Notified Body Submission
Preparation and management of complete Notified Body applications, from pre-submission meetings through conformity assessment and certification.
Technical Documentation IVDR
Development of IVDR-compliant technical documentation per Annex II & III, including GSPR checklists, benefit-risk analysis, and SSP preparation.
EU Authorized Representative IVD
EU-based Authorized Representative services for non-EU IVD manufacturers, fulfilling Article 11 obligations including EUDAMED registration.
Common Specifications Compliance
Alignment with IVDR Common Specifications (CS) that serve as mandatory performance and safety benchmarks for specific IVD categories.
Post-Market Performance Follow-up
PMPF plan development and execution to proactively collect and evaluate performance data throughout your IVD device's lifecycle.
Companion Diagnostic Regulatory
Specialized regulatory strategy for companion diagnostics (CDx) classified under IVDR Class C, including coordination with drug/therapy regulatory pathways.
Your Trusted IVDR Regulatory Partner
Navigating the EU IVDR transition requires deep expertise in IVD regulation, performance evaluation methodology, and Notified Body expectations. NexorTest delivers all three.
IVDR-Specific Expertise
Dedicated IVD regulatory team with deep understanding of IVDR Annex VIII classification rules and conformity procedures.
Notified Body Relationships
Established working relationships with IVDR-designated Notified Bodies across Europe for smoother submissions.
Performance Evaluation Excellence
In-house scientific team capable of designing and reviewing analytical and clinical performance studies.
Transition Track Record
Proven success transitioning legacy IVDD-certified devices to full IVDR compliance within regulatory deadlines.
All Classes A Through D
Experience across every IVDR risk class, including the most stringent Class D devices requiring EU Reference Laboratory review.
IVDR Certification in 6 Steps
Our structured, proven process ensures efficient IVDR compliance, minimizing timeline risks and maximizing first-time approval success.
IVD Classification Under IVDR Rules
We apply the seven IVDR Annex VIII classification rules to determine your device’s risk class (A, B, C, or D), establishing the conformity assessment pathway and Notified Body requirements.
Gap Analysis IVDD to IVDR
Comprehensive comparison of your existing IVDD documentation and compliance status against IVDR requirements, identifying every gap that needs remediation before transition deadlines.
Performance Evaluation & Evidence
Design and execution of performance evaluation studies encompassing scientific validity, analytical performance, and clinical performance to build the evidence dossier required by IVDR.
Technical Documentation Preparation
Development of complete IVDR Annex II and III technical documentation including GSPR checklist, performance evaluation report, benefit-risk analysis, and labeling review.
Notified Body Audit & Certification
Management of the full Notified Body conformity assessment process, including application submission, pre-audit preparation, QMS audit support, and technical documentation review.
EU Market Authorization & PMPF
CE marking under IVDR, EUDAMED registration, UDI assignment, and establishment of ongoing Post-Market Performance Follow-up (PMPF) and vigilance systems.
IVD Sectors We Specialize In
Our IVDR consulting expertise spans the full spectrum of in vitro diagnostic sectors and device types.
- 🩸 Clinical Chemistry Devices
- 🧹 Molecular Diagnostics
- 🔬 Immunoassay & Serology
- 🧸 Microbiology
- 🧬 Companion Diagnostics
- 🩸 Blood Banking & Transfusion
- 🩺 Point-of-Care Testing
- 🧰 Histopathology
Frequently Asked Questions About EU IVDR
Expert answers to the most common questions about EU IVDR compliance, classification, and transition requirements.
What is EU IVDR?
The EU In Vitro Diagnostic Regulation (IVDR) 2017/746 is the European regulatory framework that replaced the previous In Vitro Diagnostic Directive (IVDD 98/79/EC). It became fully applicable on May 26, 2022, and introduces a new rule-based classification system, stricter conformity assessment procedures, enhanced performance evaluation requirements, and strengthened post-market surveillance obligations for all IVD devices placed on the EU market. The transition timeline has been extended by Regulation (EU) 2024/1860 with staggered deadlines based on device risk class.
How are IVDs classified under IVDR?
Under IVDR, IVDs are classified into four risk-based classes using seven classification rules defined in Annex VIII: Class A (lowest risk, e.g., general laboratory instruments), Class B (moderate risk, the default classification for IVDs not covered by other rules), Class C (moderate-to-high risk, e.g., companion diagnostics, blood typing), and Class D (highest risk, e.g., blood screening for HIV/Hepatitis, blood grouping ABO/Rh). This new rule-based system replaces the IVDD list-based approach where devices were categorized under Annex II Lists A and B, resulting in approximately 80% of IVDs now requiring Notified Body involvement compared to only 20% under IVDD.
What are IVDR transition deadlines?
The IVDR transition deadlines, as extended by Regulation (EU) 2024/1860, are staggered by device risk class: Class D devices must have applications lodged with a Notified Body by May 2025; Class C devices by May 2026; and Class B and Class A devices with sterile or measuring function by May 2027. Manufacturers must ensure they have submitted their conformity assessment applications to an IVDR-designated Notified Body before the respective deadlines. Devices with valid IVDD certificates or self-declarations can continue to be placed on the market during the transition period, provided they meet specific conditions and their manufacturers have initiated the IVDR certification process.
What is performance evaluation under IVDR?
Performance evaluation under IVDR is the systematic process of assessing and analyzing data to demonstrate that an IVD device meets its intended performance claims. It replaces the clinical evaluation concept used for medical devices under MDR. Performance evaluation comprises three key components: scientific validity (the association of an analyte with a clinical condition or physiological state), analytical performance (the ability of a device to correctly detect or measure a particular analyte, including sensitivity, specificity, accuracy, precision, and reproducibility), and clinical performance (the ability to yield results correlated with a particular clinical condition in the target population). A Performance Evaluation Report (PER) must document all evidence gathered.
Do I need a Notified Body for IVDR?
Under IVDR, the vast majority of IVD devices require Notified Body involvement for conformity assessment — a major shift from IVDD where approximately 80% of IVDs were self-certified. Class D devices require the most stringent review, including EU Reference Laboratory verification. Class C devices require Notified Body type examination or quality management system audit. Class B devices require Notified Body quality management system certification. Only Class A devices that are non-sterile and have no measuring function can self-declare conformity without Notified Body involvement. The limited number of IVDR-designated Notified Bodies has created significant capacity constraints, making early application essential.
What documents are needed for IVDR?
IVDR technical documentation requirements (Annex II and III) include: device description and specification including all variants and accessories; information supplied by the manufacturer such as labeling and instructions for use; design and manufacturing information; General Safety and Performance Requirements (GSPR) checklist demonstrating conformity; benefit-risk analysis; product verification and validation data; a comprehensive Performance Evaluation Report with scientific validity, analytical performance, and clinical performance data; Post-Market Performance Follow-up (PMPF) plan; and for Class C and D devices, a Summary of Safety and Performance (SSP). Additionally, quality management system documentation per Article 10(9) and a UDI implementation plan are required.
How does IVDR differ from IVDD?
Key differences between IVDR and IVDD include: IVDR uses a risk-based four-class system (A, B, C, D) with seven classification rules versus IVDD’s list-based approach (Annex II Lists A and B); IVDR requires Notified Body involvement for approximately 80% of IVDs compared to about 20% under IVDD; IVDR mandates comprehensive performance evaluation including scientific validity, analytical, and clinical performance versus minimal requirements under IVDD; IVDR introduces the EUDAMED database for device registration, certificates, and transparency; IVDR requires Unique Device Identification (UDI) implementation; IVDR has significantly strengthened post-market surveillance and vigilance requirements; IVDR introduces Common Specifications as mandatory performance and safety benchmarks; and IVDR requires a Person Responsible for Regulatory Compliance (PRRC) within each manufacturer’s organization.
Can NexorTest help with IVDR Class D?
Yes, NexorTest Technologies provides comprehensive regulatory consulting for IVDR Class D devices, which represent the highest risk category including blood-borne infection screening tests (HIV, HBV, HCV, HTLV), blood grouping reagents (ABO, Rh, Kell), and companion diagnostics for life-threatening conditions. Our Class D services include: classification confirmation under IVDR rules, performance evaluation study design meeting the most stringent evidence requirements, EU Reference Laboratory coordination as required for Class D conformity assessment, Notified Body submission preparation and liaison, Common Specifications compliance verification, complete technical documentation development, and Post-Market Performance Follow-up (PMPF) plan design. We have direct experience navigating the most demanding IVDR conformity assessment procedures.
Ready to Navigate IVDR Compliance?
Don’t risk missing critical IVDR transition deadlines. Our regulatory experts are ready to assess your IVD portfolio and create a tailored compliance roadmap.
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