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IVDR Annexes — all 16

Regulatory basis

Annexes I–XVI of Regulation (EU) 2017/746 (IVDR). The IVDR contains 16 Annexes (compared to MDR's 17) that mirror the MDR structure with significant adaptations for the in vitro diagnostic context, including classification rules, conformity assessment procedures, and performance evaluation requirements specific to IVDs.

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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

Complete the Annex XI description: 'Annex XI — Product conformity verification

Parts A and B — same structure as MDR Annex XI. Part A covers production quality assurance (QA) for Class B and C devices; Part B covers product conformity verification for Class B and C devices using statistical sampling. Neither part applies to Class D devices, which use Annex IX only.'