EU IVDR 2017/746 - IVD Compliance Assessment

Evaluate compliance with European In Vitro Diagnostic Regulation 2017/746 for diagnostic tests, companion diagnostics, and laboratory-developed tests (LDTs)

MedtechBiotechHealthcareResearch25 minutes20 questions

1. Device Classification & Performance

Have you correctly classified your IVD per Annex VIII (Class A, B, C, D)?*

Article 47: Classification based on risk and intended use (companion diagnostics = Class C)

Is your IVD registered in EUDAMED with UDI assigned?*

Article 26: Registration and UDI requirements for all IVDs

For LDTs (laboratory-developed tests), do they meet IVDR requirements or exemptions?*

Article 5(5): In-house devices used within health institution under appropriate QMS

2. Quality Management System

Do you maintain an ISO 13485-compliant QMS for IVD manufacturing?*

Article 10: QMS covering design, manufacture, verification, validation

Is a person responsible for regulatory compliance (PRRC) designated with IVD expertise?*

Article 15: PRRC must understand diagnostic testing and regulatory requirements

Do you have procedures for analytical and clinical performance validation?*

Annex I (3) & (9): Performance characteristics validated per intended use

Are stability studies conducted to establish shelf life and storage conditions?*

Annex I (8): Stability must be demonstrated under stated conditions

3. Technical Documentation

Is technical documentation prepared per Annex II or III (depending on class)?*

Article 10: Technical file with device description, analytical/clinical performance

Does technical documentation include intended purpose and target population?*

Annex II: Clearly defined analytes, clinical conditions, target users

Are Instructions for Use (IFU) provided with all performance characteristics?*

Annex I (20): IFU with sensitivity, specificity, accuracy, precision, reference ranges

4. Performance & Clinical Evidence

Have you demonstrated analytical performance (accuracy, precision, LOD, LOQ)?*

Annex I (9.1): Analytical sensitivity, specificity, trueness, precision validated

Have you demonstrated clinical performance per Annex XIII?*

Article 56 & Annex XIII: Clinical sensitivity/specificity, predictive values, diagnostic accuracy

Is scientific validity established linking analyte to clinical condition?*

Annex XIII: Biological/clinical rationale for the test's intended use

For companion diagnostics, is clinical performance demonstrated with the therapeutic product?*

Article 47: Class C devices require co-validation with associated drug/therapy

Are reference materials and calibrators traceable to international standards?*

Annex I (9.2): Metrological traceability where applicable (SI units)

5. Post-Market Surveillance

Do you have a post-market surveillance (PMS) plan per Article 78?*

Article 78: PMS to monitor performance and detect emerging risks

Are Periodic Safety Update Reports (PSURs) prepared for Class C/D devices?*

Article 81: PSURs with performance data, incidents, corrective actions

Do you maintain post-market performance follow-up (PMPF) to verify performance?*

Article 56(4): Continuous collection of clinical performance data

6. Vigilance & Safety

Are serious incidents reported to competent authorities per Article 82?*

Article 82: Immediate reporting for deaths, within 15 days for serious incidents

Do you investigate and document all reported performance issues?*

Article 10(8): Root cause analysis and preventive actions

Please answer all required questions to see your results