Expert Review Panel for Diagnostics
What we do
The Expert Review Panel for Diagnostics (ERPD) is a mechanism to assess the risks and benefits associated with the procurement and use of in vitro diagnostic (IVD) medical devices that may have a substantial public health impact, but that are not in the scope of prequalification, have not yet been prequalified or undergone stringent regulatory assessment by a founding member of the Global Harmonization Task Force (now replaced by the International Medical Device Regulators Forum). The ERPD aims to facilitate access to innovative IVDs, provided the potential benefits significantly outweighs the risks associated with their use.
The ERPD is an independent advisory group of technical assessors coordinated by the WHO IVD prequalification team to assess whether candidate IVDs meet specified quality and performance expectations and determines their risk category in order to support procurement decisions.
The Global Fund (with support from Unitaid) is the principle owner for ERPD calls for expression of interest. However, other WHO programmes, NGOs and agencies can request WHO IVD prequalification to coordinate an ERPD evaluation of IVDs. Since 2023, the WHO neglected tropical diseases (NTDs) programme has launched several pilot rounds of ERPD for NTD IVDs and Gavi, the Vaccine Alliance has launched an ERPD round for vaccine-preventable diseases IVDs.
The Global Fund, GAVI and WHO NTD programme are the respective owners of the ERPD rounds and are responsible for launching the ERPD calls for expression of interest and communication with manufacturers.
To be eligible for ERPD review, an IVD must meet the state-of-the-art quality standards and performance criteria as defined in the call for expression of interest and be manufactured at a site that is compliant with ISO 13485: 2016 Medical devices – Quality management systems – Requirements for regulatory purposes. The WHO IVD prequalification team organizes the ERPD risk-benefit assessment of applications and provides recommendations to the ERPD owner for each IVD application.
Manufacturers are not charged fees for ERPD assessment.
Useful links
The owner of the ERPD call for expression of interest may choose to publish the outcomes of the ERPD assessment on their website e.g., as part of the Global Fund list of eligible IVD, or as part of the NTD ERP reviewed product list.
ERPD Terms of reference, questionnaires and calls for expression of interest can be found at the links below. Calls for expression of interest may be time-limited or may be open calls with no deadline.
The Global Fund Expert Review Panel