Introduction
With the European Union In Vitro Diagnostic Regulation (EU IVDR) now fully applicable, manufacturers must ensure that their Quality Management System (QMS) aligns with the regulation’s detailed requirements. Mapping QMS to EU IVDR is not just about ticking compliance boxes—it’s about establishing traceability, safety, and performance of IVD devices across their entire lifecycle.
This guide explains how to map your QMS to meet EU IVDR requirements, what documents and processes to include, and how to ensure continuous compliance.
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Why QMS Alignment is Critical Under EU IVDR
Under the IVDR (Regulation (EU) 2017/746), manufacturers must establish, document, implement, and maintain a QMS that covers all parts of their organization involved in the lifecycle of in vitro diagnostic devices.
A properly mapped QMS ensures:
- Smooth conformity assessment with Notified Bodies
- Consistent documentation during audits
- Fewer non-conformities and smoother technical file reviews
- Faster time to market
Unlike the previous IVDD, IVDR is much stricter and risk-based, meaning even low-risk IVDs may now fall under Notified Body scrutiny. Hence, mapping your QMS to IVDR clauses is essential for ongoing regulatory readiness.
Key EU IVDR Articles and Annexes Related to QMS
Before mapping, it’s important to understand where QMS requirements appear in IVDR. The main reference points are:
- Article 10: General obligations of manufacturers
- Annex IX: Conformity assessment based on a QMS and technical documentation
- Annex XI: Conformity assessment based on product conformity verification
- Annex XIII: Performance evaluation and post-market performance follow-up
Together, these define what the QMS must cover—from design and manufacturing to post-market surveillance.
Step-by-Step: Mapping QMS to EU IVDR Requirements
1. Start with Your Existing QMS Framework
Most IVD manufacturers already follow ISO 13485:2016 for quality management. That’s a solid foundation, as IVDR aligns closely with ISO 13485 principles. However, IVDR goes further—it demands more detailed traceability, clinical evidence, and post-market monitoring.
Action point:
Create a mapping matrix that compares your ISO 13485 clauses to IVDR requirements, particularly Article 10 and Annex IX.
2. Define Quality Objectives and Responsibilities
IVDR Reference: Article 10(8), Annex IX, Chapter I
Manufacturers must demonstrate that their QMS includes defined quality objectives, management responsibility, and resources.
What to include:
- Documented roles and responsibilities for regulatory compliance
- Appointment of a Person Responsible for Regulatory Compliance (PRRC)
- Management review records and internal audit schedules
Tip: Align management review inputs with post-market performance data and vigilance trends to meet IVDR expectations.
3. Control Design and Development Processes
IVDR Reference: Annex IX, Chapter I, Section 2.2
Design control is central under IVDR. Your QMS should document the entire design and development process—from concept to design transfer.
Ensure you cover:
- Design inputs and outputs
- Risk management (ISO 14971:2019 alignment)
- Verification and validation plans
- Design review records
- Design transfer and change control
Every design stage must demonstrate how safety and performance requirements are met.
4. Supplier and Outsourcing Controls
IVDR Reference: Annex IX, Section 2.3
Manufacturers must maintain control over suppliers, subcontractors, and service providers that affect product quality.
QMS should include:
- Supplier qualification and approval processes
- Risk-based supplier evaluation criteria
- Quality agreements and periodic performance reviews
Your Notified Body will verify that critical suppliers are monitored and controlled within your QMS.
5. Production and Process Controls
IVDR Reference: Annex IX, Section 2.4
Production and process controls ensure consistent device quality.
Include:
- Manufacturing procedures
- Equipment maintenance and calibration records
- In-process and final inspection procedures
- Batch record review and product release
Each step should demonstrate traceability back to design and risk management activities.
6. Verification of Product Conformity
IVDR Reference: Annex XI
Your QMS must ensure that every batch or product released meets specified standards.
Document controls for:
- Sampling plans
- Test methods and validation
- Product release authorizations
- Control of nonconforming products
Maintain complete traceability between test results, product batches, and certificates of conformity.
7. Post-Market Surveillance (PMS) and Vigilance
IVDR Reference: Annex III & XIII
IVDR introduces stricter post-market monitoring, requiring continuous data collection and analysis on product performance.
Your QMS must include:
- A PMS plan
- Periodic Safety Update Reports (PSURs) for Class C and D devices
- Procedures for field safety corrective actions
- Vigilance reporting timelines
PMS data should loop back into risk management and design improvements—showing a closed feedback system.
8. Documentation and Record Control
IVDR Reference: Annex IX, Section 2.4 & Article 10(8)
Proper documentation is the backbone of compliance.
Ensure your QMS covers:
- Document approval and change control
- Record retention for at least 10 years post last device placement
- Controlled access and archiving procedures
Consistency between your QMS documentation and technical documentation is vital during audits.
9. Internal Audits and Management Review
IVDR Reference: Annex IX, Section 2.3.2
Internal audits verify QMS effectiveness. IVDR requires that manufacturers proactively identify and correct deficiencies.
Include in your QMS:
- Audit schedules covering all QMS processes
- CAPA tracking and verification
- Management review summaries
This shows ongoing improvement and regulatory control.
Building a QMS-IVDR Mapping Matrix
A mapping matrix helps visualize how each IVDR clause maps to existing QMS procedures. Here’s a simplified example:
| IVDR Reference | Requirement | QMS Section / SOP |
|---|---|---|
| Article 10(8) | Manufacturer’s QMS requirements | QMS Manual – Section 4 |
| Annex IX 2.2 | Design and Development | SOP-D&D-001 |
| Annex IX 2.3 | Supplier Management | SOP-SM-002 |
| Annex IX 2.4 | Production Controls | SOP-PC-003 |
| Annex XIII | Post-Market Surveillance | SOP-PMS-005 |
Maintaining this matrix demonstrates clear alignment to auditors and speeds up conformity assessments.
Best Practices for Maintaining IVDR Compliance
- Integrate ISO 13485, ISO 14971, and IVDR requirements into a unified QMS.
- Train staff on IVDR roles and responsibilities.
- Conduct annual QMS-IVDR gap assessments.
- Keep documentation consistent across quality, regulatory, and technical files.
- Use digital tools to manage document control, CAPA, and PMS data.
Get in touch with Operon Strategist
How Operon Strategist Can Help?
Operon Strategist supports medical device and IVD manufacturers in establishing and mapping their Quality Management Systems to meet EU IVDR requirements. Our team helps bridge the gap between ISO 13485 and IVDR compliance by offering complete consulting solutions—from gap assessment and documentation to audit readiness and regulatory submissions.
With experience across global markets, we guide manufacturers through every stage of the IVDR conformity process. Whether you are upgrading your existing QMS or building one from scratch, Operon Strategist ensures full compliance, faster certification, and smooth interaction with Notified Bodies.
If your organization needs expert help in Mapping QMS to EU IVDR, reach out to our consultants to get started today.
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