12th face to face meeting of GDWG in Brussels, 21 January 2020
Key points discussed
- Expanded eligibility criteria for WHO prequalification of IVDs;
- Progress on pilot of WHO collaborative registration procedure (CRP) for IVDs;
- GDWG publication on roles and responsibilities for different types of IVD assessments;
- Collecting data for post-market surveillance.
Action points agreed
- Refinement of IVD assessment publication.
- Separate publication for end-user verification studies
- Development of PMS policy brief for QC laboratories/reference laboratories.
Sub category: Meeting report