IVDR Transition: A Real Test for QA Teams

The IVDR transition is no longer just a regulatory concept. For many manufacturers, especially those working with Class B and C in vitro diagnostic (IVD) devices, it's a reality filled with complex tasks and new documentation burdens.

Unlike Class A (self-certified), Class B and C require involvement of a Notified Body, and with it, significantly higher expectations for quality assurance (QA). If your QA team is struggling with implementing UDI systems, Post-Market Surveillance (PMS) plans, or performance evaluations, you're not alone.

This article breaks down the practical QA challenges and provides actionable lessons to help you navigate this transition with more confidence—and fewer surprises.

Why the IVDR Transition Hits Class B and C the Hardest

Most legacy IVDs previously fell under a much lighter framework. With the EU IVDR (2017/746) now fully replacing the old IVDD, the majority of products are being reclassified upwards, meaning:

• Increased technical documentation
• Expanded clinical/performance data requirements
• Stricter PMS and PMPF obligations
• Mandatory UDI compliance
• Continuous review by Notified Bodies

And that’s not just paperwork—it impacts your entire QA lifecycle, from design to complaint handling.

UDI Implementation: A QA Time Sink You Can’t Skip

If you're in QA, you've likely seen how UDI implementation can delay otherwise compliant submissions. While it seems like an IT or labelling issue, UDI is a QA responsibility at heart—it connects product data to regulatory traceability.

Key QA bottlenecks with UDI during IVDR transition:

• Master data isn’t standardized across systems (e.g., SAP, eQMS, PLM)
• Labels miss required fields due to template or language errors
• Device versions aren’t linked correctly to Basic UDI-DI
• Limited awareness on how to update UDI info in EUDAMED

Tip: Treat UDI like a mini-validation project. Build a UDI checklist in your QMS with version control, field validation rules, and training records.

PMS Plans and PMPF: Not Just Annual Reports Anymore

The IVDR significantly upgrades the scope of Post-Market Surveillance (PMS). For Class B and C devices, it’s no longer enough to react to complaints—you need structured plans, active data collection, and statistical evaluations.

Here’s what QA often overlooks:

• PMS plans are submitted as part of the technical documentation, and must align with actual risk classification and intended use
• Trend analysis must include device-specific incident rates, not just complaints
• Performance Follow-up (PMPF) requirements apply unless you justify exemption

Common QA pitfalls:

• Not updating PMS plans after major design or manufacturing changes
• Delegating PMPF evaluations to marketing or clinical teams with no QA oversight
• Using outdated vigilance processes from the IVDD era

QA must drive the integration of PMS feedback into risk management, CAPA, and design input revisions.

Performance Evaluation: The Pressure Point for Notified Body Reviews

Under IVDR, your Performance Evaluation Report (PER) becomes the centerpiece of your technical file. It must demonstrate scientific validity, analytical performance, and clinical performance—and must be reviewed regularly.

Real-world challenges QA teams report:

• Clinical performance data is weak or outdated
• Analytical testing is not traceable to qualified labs or lacks proper documentation
• GSPR Annex I references are not properly mapped in PER
• Performance studies aren’t statistically validated or are inconsistent with IFU

How QA can fix this:

• Establish a cross-functional review board (Regulatory, Clinical, QA)
• Include internal audits of PER and scientific validity statements
• Push for digital evidence management (metadata tagging of sources, traceability tables)

QA’s Role in Keeping the IVDR Transition on Track

Quality Assurance is no longer the department of checklists. During this transition, QA is the operational glue that ensures:

• Each department speaks the same “regulatory language”
• Deadlines don’t slip due to missing data or misaligned risk classes
• Notified Bodies receive a coherent, traceable technical file

If QA is looped in only during final review, delays are almost guaranteed.

Internal Lessons from Real QA Teams (What We Hear from Clients)

• "We underestimated how much PMS data we’d need to justify continued conformity."
• "UDI took longer because our ERP system wasn’t configured with correct Basic UDI-DI logic."
• "Our performance evaluation files were rejected because we didn’t justify older clinical data."
• "EUDAMED registration took weeks longer because QA wasn’t involved in coordinating the actor module setup."

These aren’t outliers. They're common across SMEs and even global manufacturers.

🔎 IVDR QA Readiness Checklist (Class B & C Devices)

✔️ UDI-DI and Basic UDI-DI codes assigned and verified across systems

✔️ Labeling templates validated for multilingual and regulatory fields

✔️ PMS Plan created, reviewed, and aligned with risk classification

✔️ PMPF plan or exemption documented and justified

✔️ Performance Evaluation Plan + Report (PER) in place and regularly reviewed

✔️ GSPR checklist fully mapped and cross-referenced to technical file

✔️ Vigilance SOPs updated to IVDR Article 87 requirements

✔️ Documented QA review of legacy clinical and analytical data

✔️ Notified Body feedback addressed and archived for traceability

✔️ EUDAMED registration completed and synced with UDI data

Final Thoughts

The IVDR transition isn’t just about regulatory compliance—it’s about transforming how quality teams support product safety and performance over time. Class B and C devices present a unique challenge because they fall into the middle of the regulatory scale—complex enough to demand deep technical files, but often under-resourced compared to Class D projects.

For QA professionals, staying involved early, asking the right questions, and owning the link between risk, documentation, and system traceability will make the difference between a smooth CE re-certification—and a failed submission.

🔗 References and Further Reading:

• Official EU IVDR Regulation (2017/746)
• MDCG Guidance on Performance Evaluation
• EUDAMED Overview (European Commission)
• UDI Helpdesk – European Commission
• MDCG 2022-12 Guidance on PMS