In-Vitro Diagnostic (IVD) Tests for COVID-19
Updated: 22 December 2020
The regulation of COVID-19 diagnostic tests
The tests used for COVID-19 are classified as in-vitro diagnostic medical devices (IVDs) that is, they analyse a sample in-vitro (outside the body) for the presence of either the virus (e.g. RNA or antigen) or the body’s immune response to the virus.
Currently tests for COVID-19 are regulated under the European In-Vitro Diagnostics Directive (IVDD, Directive 98/79/EC) and must be CE-marked and used as outlined in the accompanying product literature called instructions for use (IFU).
The HPRA’s involvement in the national response to COVID-19
The HPRA, as the national competent authority for the regulation of medical devices and IVDs, is a member of the National Public Health Emergency Team (NPHET) and other groups including the HIQA Expert Advisory Group on COVID-19 and supports the national testing strategy.
In the context of the national testing strategy the HPRA contributed to HIQA Health technology assessments published in October 2020 titled Rapid HTA of alternative tests to detect current infection with SARS-CoV-2 and in May 2020 titled Rapid HTA of alternative diagnostic testing for coronavirus 2 (SARS-CoV-2).
More information about COVID-19 testing is available below. Please click the titles below to expand each section.