Sampling of Class B and C devices under the IVD Regulation

Sampling of Class B and C devices under the IVD RegulationThe new IVD Regulation (IVDR) will require sampling of technical files for review by a Notified Body for devices classified as B or C under the regulation.

Files are sampled on a representative basis of a range devices produced by a manufacturer. This will form part of the conformity assessment by a Notified Body for those devices.

Download this whitepaper and find out:

  • The level of sampling for each class
  • The rationale to determine the number of technical files to be sampled
  • EDMA specific classification scheme for IVDs
  • LRQA sampling methodology

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