Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

Definitions

 Category of Device – As defined by the relevant IVR codes according to Regulation (EU) 2017/2185

 Generic Device Group – 3rd level of the EMDN (one letter plus 4 digits with the most appropriate IVP code

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Conformity Assessment Procedures

 Device class determines which CAP are available

 Class A: no Notified Body involvement ● Exception: sterile class A IVD

 Class B: ● QMS audit, no (scheduled) surveillance audit ● Product assessment: representative sample per category  Class C: ● QMS with annual surveillance audit and unannounced audit ● Product assessment: representative sample per generic device group

 Class D: ● See Class C plus Verification by Reference Lab ● Batch release by notified body

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