The 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