In vitro diagnostics and laboratory technology

Post-market surveillance for in vitro diagnostics (IVDs)

Post-market surveillance aims to ensure that IVDs continue to meet the same quality, safety and performance requirements as when they were initially placed on the market. Post-market surveillance consists of reactive post-market surveillance after an issue has occurred related to the IVD, and proactive post-market surveillance to scan for potential issues related to the IVD.

Reactive post-market surveillance activities include:

  • Complaint reporting, including vigilance of mild, moderate and severe adverse events;
  • Evaluation of data from external quality assessment schemes (proficiency testing); and
  • end-user quality control programmes.

For complaint reporting, the IVD manufacturer is obliged to collect and evaluate any complaint received in relation to compromised safety, quality or performance of their IVD, and undertake the necessary corrective and preventive actions, if required. National regulatory authorities and WHO play a role to collate complaints and ensure that manufacturers of WHO prequalified IVDs are conducting post-market surveillance activities.

Parties who wish to lodge a complaint about an IVD to WHO should complete the "Complaints and Product Alerts" form:

Proactive post-market surveillance activities include:

  • Lot verification testing (pre-distribution and post-distribution to end-users).

Lot verification testing aims to identify any catastrophic product failure and to determine variation from lot to the next. Lots may either be consecutively or randomly sampled for testing on a panel of well-characterised biological specimens.

WHO normative guidance on post-market surveillance of in vitro diagnostics

WHO has developed guidance on post-market surveillance for in vitro diagnostics, with specific emphasis on applicability in resource-limited settings:

The target audience for this document is:

  • National regulatory authorities and national reference laboratories;
  • end-users, procurers, implementing partners; and
  • Manufacturers.

Steps for post-market surveillance of a WHO prequalified product

Report an adverse event

Post-market surveillance for medical devices

Related Links

Emergency Use Assessment And Listing (EUAL) Procedure

ESSENTIAL MEDICINES AND HEALTH PRODUCTS

Contact us

Prequalification Team - Diagnostics
Regulation of Medicines and other Health Technologies
Department of Essential Medicines and Health Products
(HIS/EMP/RHT/PQT)
World Health Organization
20 Avenue Appia
1211, Geneva 27
Switzerland
diagnostics@who.int