The new IVD Regulation (IVDR) requires 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 of devices produced by a manufacturer. This will form part of the conformity assessment by a Notified Body for those devices, and LRQA intends to implement a process of sampling device technical documentation based on risk.
This whitepaper puts forward a rationale to determine the number of technical files to be sampled and identifies LRQA’s requirements for sampling technical files for both Class C and Class B devices. The level of sampling will be different for each class and as defined in the regulation:
For Class B devices – one representative device (technical file) per device category
For Class C devices – one representative device (technical file) per generic device group.
No definition has been given for either a generic device group or device category in the IVD regulation and therefore, LRQA has resolved this by using the European Diagnostic Manufacturers Association (EDMA) coding system.
The whitepaper also includes details on the administrative arrangements and the logic regarding the technical file sampling plan.