In-Vitro Diagnostic (IVD) Tests for SARS-CoV-2/COVID-19
Updated: 19 January 2022
The tests used for COVID-19 are classified as in-vitro diagnostic medical devices (IVDs), that is, they generally analyse a sample in-vitro (outside the body) for either the presence of the virus (e.g. RNA or antigen) or the body immune response to the virus (e.g. antibody).
Within the European medical devices legislative framework, the HPRA does not approve or certify medical devices for use or sale in Ireland or any other country. Currently tests for COVID-19 are regulated under the European In-Vitro Diagnostics Directive (IVDD, Directive 98/79/EC) and must be CE marked.
This Directive requires that devices perform safely while achieving the purpose intended by the medical device manufacturer. Medical devices which are appropriately CE marked (i.e. have undergone the appropriate conformity assessment) may be freely placed on the European market.
The CE mark for a device intended by the manufacturer for self-testing (e.g. for use by a person at home) should be labelled as such and include a 4 digit number close to the CE mark symbol which identifies the notified body responsible for certifying certain aspects of the device. For further information please see HPRA brochure on self-test products.
The current regulatory requirements for IVDs will be impacted once the new legislative framework, Regulation 2017/746 on In Vitro Diagnostic Devices (IVDR), is implemented in May 2022.
Retailers with concerns about a shortage of IVDs that may affect the Irish market should contact their supplier and the HPRA at email@example.com.
Further information on regulatory considerations are available below. Please click the titles below to expand each section.