Skip to main content

Near-patient & self-test IVDs

Regulatory basis

IVDR Art. 2(4)–(5) (definitions); IVDR Annex VIII Rules 6–7 (classification impact of self-test and near-patient format); IVDR Annex I §20 (GSPR for near-patient and self-test devices). Self-test IVDs are generally upward-classified and face additional usability requirements.

Disclaimer

This site provides general information only and does not constitute legal or regulatory advice. Always consult the official regulation text and a qualified regulatory professional.

Definitions​

Near-patient testing (NPT) / Point-of-care testing (POCT)​

Near-patient testing is IVD testing performed outside a traditional laboratory environment — at or close to the point of patient care. It includes:

  • Bedside testing in wards and ICUs
  • Testing in GP surgeries, pharmacies, and clinics
  • Emergency department rapid testing
  • Ambulance or field testing

NPT devices are designed for operation by healthcare professionals who may not be specialist laboratory scientists. They may be simpler to operate, require less sample preparation, and deliver results faster than laboratory platforms.

Self-test​

A self-test device is an IVD intended to be used by lay persons — individuals with no medical or laboratory training — in a home or non-clinical setting, without the assistance or interpretation of a healthcare professional.

Examples: home pregnancy tests, home blood glucose monitors, OTC COVID-19 antigen tests, home cholesterol tests.

Classification impact — IVDR Rules 6 and 7​

Rule 6 — Self-test upward classification​

Self-test format increases the classification compared to the equivalent laboratory test:

Laboratory classSelf-test class
Class DClass C
Class CClass C (no change)
Class BClass C
Class AClass B

Rationale: lay users are more likely to make procedural errors, misinterpret results, and act on incorrect results without professional oversight.

Rule 7 — Near-patient testing​

Near-patient testing does not automatically change classification. NPT devices are classified based on the same rules as their laboratory equivalents. However:

  • An NPT device that falls under Rule 2 (Class C) remains Class C
  • An NPT device that would be Class B in a laboratory remains Class B in an NPT format

The regulatory difference for NPT is in the GSPR and usability requirements, not classification.

GSPR specific to self-test and NPT devices​

GSPR §20 (IVDR Annex I) — Near-patient and self-testing requirements​

Devices intended for near-patient or self-testing must be designed and manufactured so that:

  • They can be used safely with minimal training (NPT) or no training (self-test)
  • The risk of error from lay users is minimised through design
  • Instructions are clear, written at an appropriate reading level, and include diagrams or pictures as needed
  • The result is presented in a format that is understandable by the intended user
  • Appropriate action advice is provided (e.g. "if your result is positive, consult your doctor")
  • The risk of incorrect self-diagnosis leading to harm is minimised

Usability engineering — IEC 62366-1​

Self-test IVDs must undergo rigorous usability testing per IEC 62366-1:2015+A1:2020 with representative lay users. This includes:

  • Formative usability testing during development (identifying and resolving design issues)
  • Summative usability testing before CE marking (demonstrating safe use by target population)
  • Studies must be conducted with the intended user population — including those with relevant health conditions, varying literacy levels, and relevant age ranges

For home blood glucose monitors: studies with people with diabetes managing their own condition. For home pregnancy tests: studies with women of reproductive age. For OTC infectious disease tests: studies reflecting the general population.

Labelling and IFU requirements for self-test devices​

Self-test IFU must be:

  • Written in plain language — no technical jargon
  • Illustrated with step-by-step pictures
  • Available in all official languages of target markets
  • Include what to do with the result (action guidance)
  • Include quality control information understandable to lay users
  • Warn about common sources of error (improper storage, expired reagents, incorrect technique)

Where electronic IFU is provided, paper IFU must still be available on request at no charge.

Post-market considerations for self-test devices​

Self-test device post-market surveillance has unique aspects:

  • Consumer complaints may be from lay users who have difficulty describing technical problems
  • Error rates in field use may differ substantially from controlled clinical studies
  • Internet and social media monitoring can capture post-market safety signals from self-test device users
  • PMPF may include structured real-world use studies

Official references​

ReferenceDescription
IVDR Art. 2(4)–(5)Definitions: near-patient and self-test
IVDR Annex VIII Rules 6–7Self-test and NPT classification rules
IVDR Annex I §20GSPR for near-patient and self-test IVDs
IEC 62366-1:2015+A1:2020Usability engineering
MDCG 2022-9Performance evaluation guidance (includes self-test)