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Expert Review Panel for Diagnostics

Expert Review Panel for Diagnostics

The Expert Review Panel for Diagnostics (ERPD) is a mechanism to review the risks and benefits associated with procurement and use of in vitro diagnostics (IVDs) that may have a high public health impact, but that are neither prequalified nor have yet undergone stringent regulatory assessment by a founding member of the Global Harmonization Task Force (now replaced the International Medical Device Regulators Forum). The principal users of ERPD are the Global Fund to Fight AIDS, Tuberculosis and Malaria and Unitaid. The Global Fund is responsible for overseeing ERPD. However, any procurer can request ERPD evaluation of IVDs. 

To be eligible for ERP assessment, an IVD must generally be manufactured at a site that is compliant with ISO 13485: 2016 Medical devices – Quality management systems – Requirements for regulatory purposes. Fees are not levied from manufacturers for ERPD assessment.

The ERPD is not intended to replace WHO prequalification  or stringent regulatory assessment, but to provide an interim solution for a time-limited period, in anticipation of the completion of a stringent review process. Thus, the ERPD mechanism may help to expedite access to innovative diagnostic products, if the associated risks are deemed to be less than the potential benefits.

Information about calls for submission of IVDs for ERPD assessment can be found in Market Information.