News

12th face to face meeting of GDWG in Brussels, 21 January 2020

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

  1. Refinement of IVD assessment publication.
  2. Separate publication for end-user verification studies
  3. Development of PMS policy brief for QC laboratories/reference laboratories.

 

Sub category: Meeting report