In Vitro Diagnostic Regulation (IVDR)

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In Vitro Diagnostic Regulation (IVDR) — EU

The In Vitro Diagnostic Regulation (IVDR) — Regulation (EU) 2017/746 — governs in vitro diagnostic (IVD)
medical devices in the European Union. It was published in 2017 and became applicable on 26 May 2022,
replacing the former IVDD. IVDR strengthens requirements for clinical evidence, quality and safety,
post-market vigilance, and traceability across the IVD lifecycle.

Regulation (EU) 2017/746
Applies since 26 May 2022
Stronger clinical evidence

Scope & key objectives

  • Scope: IVDs that examine human specimens (e.g., blood, tissue) to provide information for diagnosis, monitoring, prediction/prognosis, screening, or susceptibility.
  • Objectives: increase quality, safety, and reliability; improve transparency/traceability; enhance post-market oversight; align with state of the art.
  • Notified Body involvement: most IVDs now require NB assessment (a significant increase versus IVDD).

Classification & conformity assessment

  • Risk classes: A, B, C, D (Annex VIII). Class A (non-sterile) is lowest risk; Class D is highest (e.g., tests for life-threatening diseases, blood screening).
  • Routes: NB involvement is required for most Classes B, C, D and for sterile Class A; Class A non-sterile may be self-declared.
  • QMS: manufacturer maintains an appropriate QMS (commonly aligned to ISO 13485) covering design/production through post-market activities.

Performance evaluation & technical documentation

1) Performance evaluation (Annex XIII)
Includes scientific validity, analytical performance, and clinical performance, concluding in a Performance Evaluation Report (PER). For many IVDs, a performance study may be required.
2) Technical documentation (Annex II & III)
Device description/intended purpose, risk management, design/manufacture info, performance evaluation evidence, verification/validation (e.g., stability, usability, software), labeling/IFU, and post-market plans.
3) PMS & PMPF
Post-Market Surveillance (PMS) proportionate to risk and Post-Market Performance Follow-up (PMPF) where appropriate to keep evidence current through the lifecycle.

Market access enablers

  • UDI & traceability: Unique Device Identification and labeling requirements; device/actor registrations.
  • EUDAMED: use of EU databases for actor registration (SRN), UDI/device data, and vigilance as modules become fully functional.
  • Economic operators: defined responsibilities for manufacturer, authorized representative, importer, and distributor.
  • Legacy & transition: transitional provisions for eligible IVDD-compliant (“legacy”) IVDs with staggered deadlines by class; documentation and PMS must remain compliant during transition.

Quick checklist

  • Clear intended purpose drives classification and evidence.
  • Performance evaluation covers scientific validity, analytical, clinical with a robust PER.
  • Technical documentation aligns to Annex II/III and maps to GSPRs (Annex I).
  • Appropriate QMS in place; supplier and production controls are risk-based.
  • UDI/labeling and EUDAMED actor/device obligations planned.
  • PMS & PMPF proportionate to risk; vigilance and trend reporting defined.

IVDR — FAQs

What changed from IVDD to IVDR?
Broader NB involvement, risk-based classification (A–D), stronger performance evaluation (scientific validity, analytical, clinical), expanded PMS/PMPF, UDI/traceability, and clearer economic-operator duties.
Do all IVDs need a Notified Body?
Most do (Classes B, C, D and sterile Class A). Class A non-sterile may be self-declared provided all applicable requirements are met.
What is required for performance evaluation?
A documented plan and evidence covering scientific validity, analytical performance, and clinical performance, concluding in a PER; PMPF keeps evidence current post-market.
How do transitional provisions work?
Eligible IVDD legacy IVDs may benefit from staggered IVDR transition timelines by class, subject to conditions (e.g., no significant changes, ongoing PMS/vigilance). New devices must comply with IVDR.
What post-market reports are expected?
All devices require PMS; higher-risk classes typically include a PSUR cadence, while lower-risk may maintain a PMS report—frequencies are proportionate to class and risk.