10th face-to-face meeting of GDWG in Abuja, 9 December 2018
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
- 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.
- 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.
- Support development of a WHO policy brief on post-market surveillance for analyser-based IVDs, including acceptable failure rates.
- Develop a standardised format for certificate of analysis specific for IVDs
Sub category: Meeting report