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Summary

IVDR device classification determines your in vitro diagnostic medical device’s risk class (A, B, C, or D) under EU In Vitro Diagnostic Medical Device Regulation 2017/746, which directly impacts your conformity assessment procedure, notified body requirements, and market access timeline. Classification is based on your device’s intended purpose, clinical significance, and potential impact on patient management according to the specific rules in Annex VIII. Accurate classification is mandatory for CE marking and commercialization of IVD devices in the European Union.

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Why is IVDR Device Classification Important?

IVDR classification is critical for your regulatory strategy because it determines the level of regulatory oversight, required clinical evidence, and conformity assessment pathway. Higher-risk classifications (Class C and D) require notified body involvement, extensive clinical performance studies, and more rigorous quality management systems. Misclassification can result in significant delays, increased costs, or inability to market your device. Your classification also affects your post-market surveillance obligations, the depth of technical documentation required, and the timeline for achieving CE marking under the IVDR transition period.

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Regulatory Context

Under EU IVDR 2017/746, Annex VIII:
  • Classification rules are mandatory and specific to IVD characteristics
  • Based on clinical significance, intended purpose, and patient impact
  • Determines conformity assessment procedure under Annex IX, X, or XI
  • Class C and D devices require notified body involvement and clinical performance studies
Special attention required for:
  • Companion diagnostics - typically Class C under Rule 3f
  • Self-testing devices - Rule 4a with specific exceptions for Class B
  • Blood grouping and tissue typing - Rules 2a-2e typically result in Class D
  • Software IVDs - apply general classification rules based on clinical impact

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Guide

IVDR classification follows specific rules in Annex VIII that focus on clinical significance and patient impact. Unlike MDR classification, IVDR rules are more directly tied to the clinical consequences of incorrect results rather than physical device characteristics. Start with the highest-risk categories (Rules 1-2). Rule 1 covers devices for detecting transmissible agents in blood, tissues, or organs, and devices for life-threatening diseases with high propagation risk - these are typically Class D. Rule 2 addresses blood grouping and tissue typing, with specific markers (ABO, Rhesus, Kell, Kidd, Duffy) resulting in Class D classification. Evaluate clinical significance rules (Rule 3). This comprehensive rule covers many clinically significant applications including sexually transmitted agents, infectious agents in blood/CSF, companion diagnostics, cancer screening/diagnosis/staging, genetic testing, and therapeutic drug monitoring. Most applications under Rule 3 result in Class C classification. Consider self-testing and near-patient testing (Rule 4). Self-testing devices are generally Class C, with specific exceptions for pregnancy, fertility, cholesterol, glucose, and urine testing (Class B). Near-patient testing devices are classified based on their specific intended purpose. Apply general laboratory rules (Rules 5-7). Rule 5 covers general laboratory products and instruments (Class A). Rule 6 is a catch-all for devices not covered by other rules (Class B). Rule 7 addresses controls without assigned values (Class B). Document your classification rationale thoroughly. Reference the specific IVDR Annex VIII rule applied, explain the clinical significance of your test, and justify why other rules don’t apply. Consider the consequences of false positive and false negative results on patient management. Consider software and algorithm components. Software IVDs are classified based on their clinical impact using the same rules as hardware devices. AI/ML algorithms that provide diagnostic information follow the same classification principles based on clinical significance.

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Example

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Complete IVDR Classification Document

IVDR Classification Document ID: IVDR-CLASS-2024-001

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Device Classification

Class C

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Device Classification Justification

The CardioGenetic Risk Panel is classified as Class C under EU IVDR 2017/746 based on the following analysis of Annex VIII classification rules: Rule 3i (Human genetic testing): The CardioGenetic Risk Panel is an in vitro diagnostic device intended for human genetic testing to identify genetic variants associated with inherited cardiac conditions including hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, and long QT syndrome. Under Rule 3i, devices for human genetic testing are classified as Class C. Clinical Significance Analysis: The test analyzes genetic variants in genes including MYH7, MYBPC3, TNNT2, TNNI3, SCN5A, and KCNQ1 that are associated with inherited cardiac conditions. Results are used by healthcare providers to:
  • Assess genetic risk for developing cardiac conditions
  • Guide family screening recommendations
  • Inform clinical management decisions including surveillance frequency
  • Support reproductive counseling decisions
Impact of Erroneous Results:
  • False Positive: Could lead to unnecessary anxiety, inappropriate clinical surveillance, and family screening. May result in lifestyle restrictions or medical interventions that are not clinically indicated.
  • False Negative: Could result in missed diagnosis of genetic predisposition, inadequate clinical surveillance, and failure to implement appropriate family screening protocols. This could lead to undiagnosed cardiac events in the patient or family members.
Other Rules Considered:
  • Rule 1: Not applicable - device does not detect transmissible agents or life-threatening diseases with propagation risk
  • Rule 2: Not applicable - device does not perform blood grouping or tissue typing
  • Rule 3c: Not applicable - while cardiac conditions can be serious, the genetic testing context does not meet the criteria for “erroneous result could cause death or severe disability”
  • Rule 3g: Not applicable - device is not used for disease staging
  • Rule 3h: Not applicable - device does not screen, diagnose, or stage cancer
  • Rule 4: Not applicable - device is not intended for self-testing
  • Rule 6: Not applicable - device is specifically covered under Rule 3i
Conclusion: The CardioGenetic Risk Panel is classified as Class C under Rule 3i for human genetic testing. This classification reflects the clinical significance of genetic information for inherited cardiac conditions and the potential impact on patient and family management decisions.

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Q&A

Software IVDs are classified using the same rules as hardware devices based on their clinical significance and intended purpose. Apply the relevant Annex VIII rules based on what the software does clinically, not its technical implementation. AI/ML algorithms that provide diagnostic information follow the same classification principles - focus on the clinical impact of the results, not the underlying technology.
Class D devices typically involve life-threatening conditions with high propagation risk (Rule 1) or critical blood/tissue compatibility testing (Rule 2). Class C devices cover most other clinically significant applications including companion diagnostics, cancer testing, genetic testing, and therapeutic drug monitoring. The key difference is the immediacy and severity of clinical consequences from incorrect results.
Companion diagnostics are typically Class C under Rule 3f. These are devices used to identify patients who are most likely to benefit from a particular therapeutic product or to identify patients likely to be at increased risk for serious adverse reactions. The classification reflects the significant impact on treatment decisions and patient safety.
Self-testing devices are generally Class C under Rule 4a, with specific exceptions for pregnancy, fertility, cholesterol, glucose, and certain urine tests which are Class B. Self-testing devices are never Class A (which is reserved for general laboratory products) and rarely Class D unless they also meet Rule 1 or Rule 2 criteria for other reasons.
Unlike MDR, IVDR rules are generally mutually exclusive and specific to particular applications. However, if multiple rules could theoretically apply, document your analysis of each rule and explain why the selected rule is most appropriate. Focus on the primary intended purpose and clinical application of your device.
Document your clinical significance analysis, including the consequences of false positive and false negative results on patient management. Reference the specific Annex VIII rule applied and explain why other rules don’t apply. Include evidence of your device’s intended purpose, target population, and clinical context. This documentation will be reviewed by your notified body for Class C and D devices.