News and Events

Key points discussed

• Expanding the eligibility criteria for WHO prequalification of IVDs, and expanding the WHO collaborative registration procedure (CRP) to IVDs
• Presentation on a business case for development of end-user quality control material for post-market surveillance of IVDs
• Launch of the GDWG website  

Action points agreed

1. Support verification studies for end-users thus moving away from in-country evaluations that duplicate work performed within the regulatory assessment process or performance evaluations for in-country uptake decisions.
2. Expand post-market surveillance of IVDs , firstly through development of a position paper for how IVD end-users can collect data for post-market surveillance.
3. Support development of a WHO policy brief on post-market surveillance for analyser-based IVDs, including acceptable failure rates.
4. Develop a standardised format for certificate of analysis specific for IVDs