Commission publishes document on ‘Current performance of COVID-19 test methods and devices’

The European Commission has published a ‘Working Document of Commission Services’ to address issues surrounding the ‘Current performance of COVID-19 test methods and devices and proposed performance criteria’.

The 32 page document Executive Summary explains that:

“When assessing conformity with the legislation and prior to affixing the CE-mark, the manufacturer must evaluate the performance of the device and report the performance information in the instructions for use and technical documentation of the device. This is usually achieved by conducting performance studies. In addition to this, after being placed on the market the performance of devices may be validated, i.e. confirmed by additional testing that the manufacturer’s specifications are indeed satisfied, e.g. in reference laboratories, academic institutions or national regulatory agencies. Such validation is not legally obligatory but highly recommended for public health decision making, especially in the context of the current COVID-19 crisis. Validation can be done not only for CE-marked devices but should also be performed for in-house laboratory protocols.