The in vitro diagnostic regulation – what can SKUP do to help?
Information generated from a SKUP evaluation serves as valuable documentation for the analytical performance of in vitro diagnostic (IVD) medical devices which can be used in the manufacturer’s documentation for CE marking.
SKUP evaluations provides manufactures with objective information to help demonstrate the analytical performance and user-friendliness of IVD medical devices, particularly for self-testing and near-patient testing. A comprehensive report from a SKUP evaluation includes the following analytical performance indicators:
- Precision
- Bias (against validated clinical laboratory method)
- Accuracy
- Diagnostic sensitivity and specificity (for qualitative test results only)
- User-friendliness rated by the intended users.
Evaluations are conducted following a standardised protocol, with the practical part carried out by the intended users of the measuring system. The protocol contains detailed procedures, including, but not limited to, sample collection, evaluation sites and personnel involved, training, result recording, calculation of analytical performance, and assessment of user-friendliness.
The protocol is approved by the manufacturer before the evaluation begins. Once evaluation data is collected, SKUP prepares a report and sends it to the manufacturer for review and comments. The report for the manufacture contains raw data and includes results from the comparison method and internal analytical control results from the measuring system. The report without raw data is published on SKUPs website if the IVD device is marketed in Scandinavia.
The manufacturer can request further investigations or calculations to be included in the evaluation, however, this must be agreed upon with SKUP in advance and included in the protocol.
Parts of the report, or the whole report, can be used in the manufacturer´s documentation for CE marking.
For additional information, please contact SKUP.
