⚠️ Important Update – Changes to WHO’s Prequalification of IVD Assessment Pathway (from 2026)

WHO’s assessment procedure for Performance Evaluation Laboratories for in vitro diagnostics is currently under revision. This webpage will be updated with new guidance documents once available.  For further information, please email WHO’s Prequalification of IVDs team at diagnostics@who.int.

Why participate?

WHO’s performance  evaluation of in vitro diagnostics (IVDs) enables WHO to verify certain standards of performance that are considered essential for resource-limited settings. These evaluations must be performed by a designated Performance Evaluation Laboratory (PEL). 

Laboratories that successfully apply to become a PEL contribute to WHO's aim to increase access to IVDs for accurate diagnosis and monitoring of priority disease and conditions.

Requirement for WHO listing

WHO requirements for listing of a performance evaluation laboratory are specifically related to performance evaluations. An assessment will ascertain the potential for a laboratory to undertake a performance evaluation according to the relevant WHO protocol, as well as the laboratory’s compliance with the principles of ISO/IEC 17025:2005 and ISO 15189:2012. Additional references relating to good practice for laboratories performing IVD evaluations, including other ISO standards, will be referred to during the audit. The auditing process is based on the principles outlined in ISO 19011:2018.

Assessment process

Assessment of a candidate laboratory consists of:

• Submission by the laboratory of a completed expression of interest (EOI) and supporting documentation.
• Stage 1 assessment: assessment by WHO of the EOI and the specific quality management system (QMS) documentation submitted by the manufacturer.
• Stage 2 assessment: on-site audit by WHO of the laboratory to assess compliance with WHO requirements.
• If the laboratory meets all requirements, listing of the laboratory as a WHO Performance Evaluation Laboratory.

Laboratories that meet assessment requirements will be informed by letter of their listing as a PEL.

Performance Evaluation Laboratories must ensure ongoing compliance with WHO requirements following listing.