IVD Emergency Use Assessment and Listing Procedure (EUAL) for candidate in vitro diagnostics (IVDs) for use in the context of a public health emergency (7 July 2015) PDF Guideline/guidance
M ePQS - External Guidance – API Prequalification Application - Wizard Guidance PDF Guideline/guidance
M ePQS - External Guidance – APIMF Post-PQ Change Application - Wizard Guidance PDF Guideline/guidance