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IVD Classification

Overview​

In vitro diagnostic (IVD) medical devices are subject to a separate classification system under the SFDA framework, broadly aligned with IMDRF IVD risk classification principles and structurally similar to EU IVDR 2017/746 — though applied independently by the SFDA.

IVD risk classes​

The SFDA classifies IVDs into risk categories based on the risk associated with incorrect results:

ClassRisk levelTypical examples
Class A (IVD)Low individual / low public health riskGeneral laboratory instruments, buffer solutions, microbiological culture media
Class B (IVD)Moderate individual / low public health riskUrinalysis reagents, non-high-risk pregnancy tests, general haematology analysers
Class C (IVD)High individual / moderate public health riskBlood glucose tests for self-monitoring, PSA screening tests, thyroid function tests
Class D (IVD)High individual / high public health riskHIV tests, hepatitis B and C tests, blood grouping and Rh factor determination, NAAT for high-risk pathogens
Highest IVD classes

Class D IVDs — which include tests for life-threatening and highly transmissible infectious diseases — are subject to the most rigorous SFDA review, the most detailed technical file requirements, and mandatory annual PSURs.

How to classify an IVD​

Classification is determined by applying the SFDA's IVD classification rules (in MDS-REQ 1), considering:

  1. The analyte or marker detected
  2. The intended purpose — screening, diagnosis, monitoring, or risk stratification
  3. The intended user — professional or lay (self-test)
  4. The public health risk — how dangerous incorrect results would be at a population level

Self-test IVDs (intended for use by lay persons) typically carry a higher classification than equivalent professional-use IVDs due to the reduced training and contextual interpretation available to the user.

Technical file differences for IVDs​

While the overall technical file structure is similar to general medical devices, IVDs have specific requirements in the Product Verification and Validation section:

  • Analytical performance data (accuracy, precision, specificity, sensitivity)
  • Clinical performance data — comparison with reference method or gold standard
  • Reference intervals and cut-off values
  • Interference studies
  • Stability testing

MDMA for IVDs​

All IVDs require MDMA via the TFA route. Grouping of IVDs in a single MDMA application is permitted (up to 50 items), provided they share the same legal manufacturer, risk class, and intended use. See Device Grouping.

Further reading​