IVDR-QMS Compliance Checklist
In Vitro Diagnostic Regulation (IVDR) QMS compliance is a legal requirement under Article 10 of the Regulation (EU) 2017 / 746 (EU IVDR) and is critical to continue marketing legacy IVD products beyond May 2025. It ensures that IVD manufacturers comply with EU regulations for device safety, performance, risk management, and post-market surveillance.
An IVDR & ISO 13485 compliant QMS is also mandatory for Notified Body certification, which is needed for most in vitro diagnostic devices under Regulation (EU) 2017 / 746 (EU IVDR). QMS compliance drives regulatory robustness with reduction in the regulatory risk, supporting lifecycle compliance, and builds trust with stakeholders. Failure to establish an IVDR-compliant QMS may result in loss of IVDR transition period benefits, inability to certify products, forced market withdrawal, and significant business & reputational impact in the European Union Market.
1. General QMS Requirements
â–¢ ISO 13485:2016 alignment: Your QMS should be built around ISO 13485, with additional IVDR-specific enhancements.
â–¢ Regulatory Strategy: Clearly define how the QMS supports IVDR compliance across device lifecycles.
â–¢ Document Control: Ensure robust control of quality documents, version tracking, approvals, and retention.
â–¢ Training System: Evidence of IVDR-specific training for relevant staff; training matrix updated.
â–¢ Change Management: Strong process to identify, evaluate, and control changes, especially changes impacting conformity & product quality.
2. Technical Documentation
â–¢ Structure per Annex II & III: Organize technical files to follow IVDR Annex II (Device Description, Design & Manufacturing Info, Performance Evaluation, etc.)
â–¢ Device Classification Rationale: Document classification logic under IVDR rules and MDCG IVDR classification guidance.
â–¢ Labeling & Unique Device Identifier (UDI) included: Device labels, UDI, and Instructions for Use (IFU) must be included.
â–¢ Declaration of Conformity (DoC): Prepare DoC with product details & relevant conformity assessment procedure.
3. Risk Management (ISO 14971 Integrated)
â–¢ End-to-end risk process: Application of risk management to design, manufacturing, post-market elements.
â–¢ Risk-Benefit Justification: Updated per performance evaluation and PMS data.
â–¢ Risk File Updates: Include findings from CAPAs, complaints, field actions.
4. Performance Evaluation (Annex XIII)
â–¢ Scientific Validation Reports (SVR): Show how the analyte and intended use are supported by literature or studies.
â–¢ Analytical Performance: Sensitivity, specificity, precision, linearity, etc., with validation reports.
▢ Clinical Performance: Clinical evidence demonstrating device’s intended purpose in the target population.
â–¢ Performance Evaluation Report (PER): provides evidence that an IVD device is safe, performs as intended and updated with PMS findings.
5. Post-Market Surveillance (PMS) and Vigilance
â–¢ PMS Plan per Annex III, Part A: Proactive system for data collection and trend analysis.
â–¢ PMS Report (Class A & B) or Periodic Safety Update Report (PSUR) for Class C & D: Summarized results and conclusions of PMS.
â–¢ Vigilance System: Standard Operating Procedures (SOPs) for incident reporting, timelines met (e.g., serious incidents within 15 days).
â–¢ Trend Reporting: Defined thresholds and procedures for trend analysis.
6. PRRC (Person Responsible for Regulatory Compliance) – Article 15
â–¢ Appointed Individual(s): Either internal staff or contracted resource if SME with an appointment letter documented.
â–¢ Qualifications Evidence: Degree and experience as per Article 15(1).
â–¢ PRRC Responsibilities in QMS: Oversight of technical documentation, conformity, PMS, and reporting.
7. UDI System & EUDAMED Preparedness
â–¢ UDI assignment per Part C, Annex VI: Applied at the correct levels (device, packaging, etc.).
â–¢ UDI Labelling: Included on packaging and IFU.
â–¢ EUDAMED readiness: Legal Manufacturer / Importer /Authorised Representative registration with a Single Registeration Number (SRN), device registration modules as applicable.
â–¢ Basic UDI-DI maintained: Links devices of the same family.
8. Supplier and Outsourced Activities Management
â–¢ Approved Supplier List (ASL): Updated with risk-based qualification.
â–¢ Supplier Agreements: QAA/CTA in place for critical processes (e.g., sterilization, software development).
â–¢ Monitoring: Metrics to track supplier performance, audits scheduled.
â–¢ Verification of Purchased Products: Documented inspections/tests.
9. Labelling, IFU, and Marketing Materials
â–¢ Label Content (Annex I, Section 20): Device name, UDI, manufacturer info, lot number, expiry, etc and symbols as per ISO 15223
â–¢ Translations: Accurate and verified for each EU market.
â–¢ IFU Review: Includes warnings, contraindications, use instructions; format and font compliant with accessibility expectations.
â–¢ Claims Consistency: Align all marketing materials and labeling with the intended use and performance claims in the technical file.
10. Notified Body Engagement and Readiness
▢ Early NB Engagement: Critical for Class B/C/D devices — ensure slots are booked early due to capacity constraints.
â–¢ Gap Analysis Completed: Identify shortfalls between current state and IVDR expectations.
â–¢ Mock Audits: Internal or third-party pre-assessments to verify readiness.
▢ Submission Timeline: Plan the NB submission timelines from applicable transition deadline (2025–2027), with internal milestones.
In conclusion, achieving IVDR QMS compliance is a mandatory and non-negotiable step for any IVD manufacturer looking to market devices in the European Union. By following the comprehensive checklist outlined in this article, companies can ensure they meet the applicable regulatory requirements as per IVDR.
Partnering with RegTrac will streamline this complex process, offering expert guidance to help your organization implement a robust, compliant QMS that aligns with IVDR standards in less than 4 weeks! Write to us at info@reg-trac.com or schedule a free consultation to discuss today!
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