The European Commission launched COVID-19 In Vitro Diagnostic Devices and Test Methods Database
The European Commission launched the JRC COVID-19 In Vitro Diagnostic Devices and Test Methods Database. The objective of this database is to collect in a single place all publicly available information on performance of CE-marked in vitro diagnostic medical devices as well as in-house laboratory-developed devices and related test methods for COVID-19.
“The Commission, supported by the ECDC, health technology assessment experts and in vitro diagnostics competent authorities, will assist Member States with a centralised overview of available information on test performance and act as a single point of contact for management of this information. Taking stock of the state of the art on a regular basis will support Member States’ informed decisions on national testing strategies, as well as support the continuous development of devices by manufacturers.”
For CE-marked devices, only the information that the manufacturer has chosen to make publicly available is included in this database. Full information on the manufacturer’s performance evaluation of the device is contained in the technical documentation required by the EU legislation. Manufacturer technical documentation is usually not publicly available and is therefore not included here.
For more details, please see the press release from the European Commission.
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This article provides general information and does not constitute regulatory or legal advice. Requirements should be confirmed for the specific study, applicable regulatory framework, and markets concerned.
