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IVDR Annexes — all 16

Regulatory basis

Annexes I–XVI of Regulation (EU) 2017/746 (IVDR). The IVDR annexes mirror the MDR structure with adaptations for the in vitro diagnostic context.

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This page provides summaries for navigation. Always consult the full official text for compliance purposes.

Annex I — General Safety and Performance Requirements (GSPR)​

Parallel to MDR Annex I but adapted for IVDs:

  • Chapter I (§1–5): General requirements — safety, risk management, performance, state of the art. Same structure as MDR.
  • Chapter II (§6–16): Design and manufacture — with IVD-specific requirements for specimen handling, analytical precision, calibration traceability, and interference testing.
  • Chapter III (§17–20): Information supplied — labelling and IFU requirements adapted for IVDs, including expected values, reference ranges, and specimen requirements.

→ See GSPR overview

Annex II — Technical documentation​

Same six-section structure as MDR Annex II, with IVD-specific content:

  1. Device description and specification — including analytes, specimen types, measurement range
  2. Information supplied — IVD-adapted labelling and IFU
  3. Design and manufacturing information — reagent formulation, manufacturing process, analytical validation
  4. GSPR cross-reference table
  5. Benefit-risk analysis and risk management
  6. Verification and validation — analytical performance studies, performance evaluation report

→ See Technical documentation overview

Annex III — Technical documentation on post-market surveillance​

Mirrors MDR Annex III:

  1. PMS plan
  2. PSUR (Class C and D) or PMS report (Class A and B)
  3. PMPF plan and PMPF evaluation report

→ See Post-market data in technical documentation

Annex IV — EU Declaration of Conformity​

Same content requirements as MDR Annex IV adapted for IVDR regulatory references.

Annex V — CE marking​

Identical requirements to MDR Annex V.

Annex VI — Information to be submitted to EUDAMED​

Economic operator registration data and UDI-DI / UDI-PI information for IVDs — adapted for IVD-specific data elements (analyte, specimen type, measurement range).

Annex VII — Requirements for notified bodies​

Same structure as MDR Annex VII. Notified bodies seeking IVDR designation must demonstrate competence in IVD-specific areas:

  • Analytical chemistry and immunoassay methodology
  • Molecular diagnostics (PCR, NGS, etc.)
  • Clinical laboratory operations
  • IVD regulatory experience
  • Performance evaluation methodology

Annex VIII — Classification rules (Rules 1–7)​

The seven IVDR classification rules:

  • Rule 1: Class D — highest risk (HIV confirmation, blood group typing, NAT for blood screening, TSE)
  • Rule 2: Class C — significant individual patient impact (glucose, HbA1c, troponin, companion diagnostics, genetic tests, rubella/toxoplasma serology)
  • Rule 3: Class B — routine clinical diagnostics (routine haematology, chemistry, general serology)
  • Rule 4: Class A — lowest risk (general instruments, specimen receptacles, buffers)
  • Rule 5: Class A — instruments (assigned A unless used exclusively with higher-class assay)
  • Rule 6: Self-test upward reclassification (Class D self-test → Class C; Class B self-test → Class C; Class A self-test → Class B)
  • Rule 7: Near-patient testing — no automatic reclassification; classified by analyte rules

→ See IVDR classification rules 1–7

Annex IX — Conformity assessment based on QMS and technical documentation​

Parallel to MDR Annex IX with IVD-specific adaptations:

  • Class D only route (no Annex X + XI alternative)
  • EU reference laboratory review required for Class D (Section 4)
  • Class D batch testing requirements
  • For companion diagnostics: EMA/NCA consultation procedure (Art. 48(3))

→ See Conformity assessment overview

Annex X — EU type examination​

Available for Class B and C IVDs. Used in combination with Annex XI. Not available for Class D.

Annex XI — Product conformity verification​

Parts A and B — same structure as MDR Annex XI. Production quality assurance (Part A) or product verification (Part B).

Annex XII — Certificates issued by notified bodies​

Specifies required content of IVDR certificates. Includes validity period (maximum 5 years; renewable).

Annex XIII — Performance evaluation and post-market performance follow-up (PMPF)​

Two parts:

  • Part A: Performance evaluation stages — scientific validity, analytical performance, clinical performance; literature search methodology; performance evaluation report (PER)
  • Part B: PMPF — proactive post-market performance data collection; PMPF plan; PMPF evaluation report

→ See Performance evaluation

Annex XIV — Performance studies​

Detailed requirements for performance studies:

  • General requirements for all performance studies
  • Documentation requirements
  • Obligations during performance studies
  • Interventional vs. non-interventional performance studies

→ See Performance studies

Annex XV — Correlation table​

Maps IVDD (98/79/EC) articles and provisions to corresponding IVDR provisions. Useful reference for manufacturers transitioning from IVDD.

Annex XVI — (Reserved)​

Currently reserved; no content assigned.

Official references​

ReferenceDescription
IVDR 2017/746, Annexes I–XVIFull annex texts
EUR-Lex consolidated IVDRCurrent version including all amendments