The regulation introduces the classification of IVD in the risk classes A, B, C, and D (§47). There are seven classification rules that are given in Annex VIII. MDCG guidance 2020-16 provides clarification of the classification rules and gives classification examples.MDCG 2020-16 Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 Only devices in the lowest risk class, class A, are excluded from the requirement of notified body oversight.
