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10th face-to-face meeting of GDWG in Abuja, 9 December 2018

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

  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
Sub category: Meeting report
Years: 2018