Class D IVDs are critical for public health. They mainly fall into two categories: a) those related to blood, cells, tissues or organ screening, and b) those related to management of lifethreatening infectious diseases. Under the In vitro Diagnostic Medical Devices Regulation
2017/746/EU (IVDR), Class D devices rely on a complex infrastructure whose elements must work together: Common Specifications1, Expert Panel assessment2, Notified Body review, and evaluation by EU Reference Laboratories3. MedTech Europe has always supported the full and early establishment of all needed infrastructure for Class D devices…
