EU IVDR 2017/746 implements significant changes including:
A life cycle approach requiring effective manufacturer quality management systems to ensure more thorough and transparent maintenance accompanied by living documentation to prove post-market performance.
New classification criteria using a rule-based system categorizing products into four risk classes, ranging from Class A (lowest risk) to Class D (highest risk).
Notified Body review mandating products in Class A-Sterile and Class B or higher to be approved for CE marking by a separate authorized entity or Notified Body overseen by a competent authority to eliminate individual interpretation of the requirements.