Sampling for Assessment of Technical Documentations according to IVDR Annex IX



Sampling of Class B and C IVD Devices

Article 48(7) and (9) of Regulation (EU) 2017/ 746 on in vitro diagnostic medical devices (IVDR) establish the requirement to assess technical documentation of at least one representative device per generic device group (for Class C) and for each category of devices (for Class B) before issuing a certificate to a manufacturer.

This report sheds light on the aspects of the sampling plan, practical implications of sampling, and more.

Complete the form to download the report.

Download the report to learn:

  • Sampling plan in the context of the IVDR
  • Examples of device categories and generic device groups
  • Practical implications of sampling

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