Nowadays, the Med-Tech industry is facing an essential challenge and duty in making safe and reliable Covid-19 diagnostic tests available.
In order to place an In-vitro diagnostic device on the EU market the manufacturer must, among others, evaluate the performance of the device and report the related information in the Instructions for Use and Technical Documentation of the device, accordingly to the applicable EU law (Directive 98/79/EC and, from May 26, 2022, Regulation (EU) 2017/746).
On April 15, 2020, the European Commission published a new working document covering performance and validation of different currently available Covid-19 tests and additionally proposing the performance criteria. This comes in aid of Economic Operators providing supporting information describing the analytical and clinical performance of a test.
The evaluation was performed by the Joint Research Center (JRC), with the aim of:
- Collecting and reviewing publicly available information from manufacturers on commercially available devices for COVID-19;
- Reviewing performance assessment studies of such test methods performed by academic institutions, National Regulatory Agencies, international organizations, Health Technology Assessment (HTA) Bodies, reference laboratories and similar organizations.
The developed criteria are based on the principles of good analytical practice and the corresponding international standards, such as ISO/IEC 17025 and ISO 15189, and are intended as additional guidance to the requirements laid down in the Directive 98/79/EC.
Accordingly to the information collected, the evidence on the reliability and comparability of most Covid-19 tests is still limited. Indeed, among RNA tests, Commission services still recommend to use tests that ‘’explicitly declare the implementation of a WHO protocol, of which also validated versions are available’’.
Given the state of emergency, the Commission proposes actions in the following weeks to pool resources for the validation of coronavirus tests at EU-level, to address critical performance-related aspects.
If you are a manufacturer of IVDs for Covid-19 detection, you cannot miss this document, and remember to continuously check and validate your devices’ performance following the state of the art!
Consult the EC document here and the related Annexes:
- Annex 1: Commercial devices
- Annex 2: Scientific literature
- Annex 3: Search on validation studies
Filippo Chierchini
Regulatory Affairs Department
25/05/2020
For more information on Covid-19 related In-Vitro Diagnostics devices, do not hesitate to contact our Regulatory Affairs experts!