This Excel spreadsheet is designed to support manufacturers making the transition from IVDD to IVDR. It is specifically designed for the area of IVDD “essential requirements” vs. IVDR “general safety and performance Requirements” Annex I. This checklist once filled out establishes the objective evidence for the IVDR compliance. In addition, it still provides the same for the IVDD compliance.
You will receive the document within 24 hours after payment.