TÜV SÜD — IVDR Transition Guide: From IVDD to EU 2017/746
Summary
Comprehensive guide on transitioning from the In Vitro Diagnostic Directive (98/79/EC) to the EU IVDR (2017/746). Covers the new risk-based classification system (Classes A, B, C, D), performance evaluation requirements, and extended transitional periods per Regulation (EU) 2023/607.
Document Details
Document IDTUVSUD-IVDR-GUIDE
TypeWhite Paper
AuthorityTÜV SÜD (NB 0123)
Publication Date2023-09-01