In-Vitro Diagnostic (IVD) Tests for SARS-CoV-2/COVID-19

Updated: 18 June 2021

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 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.

The IVDD 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.

Further information on regulatory considerations are available below. Please click the titles below to expand each section.

Limitations of Tests

In order to achieve the performances claimed by the manufacturer for the device, the test should be used according to the instructions for use (IFU) provided by the manufacturer. When performing any test, the user is advised to read the IFU prior to use. Particular attention should be paid to the specified sample type required (e.g. saliva, anterior nasal, oropharyngeal, nasopharyngeal swab, blood), the instructions for sample collection and the specified limitations for the test, for example, including but not limited to:

  • There is a risk of false positive and false negative results with all in-vitro diagnostic tests.
  • Failure to follow the IFU may affect test performance and impact the validity of the test result.
  • Positive results need to be considered alongside other clinical information such as past medical history, results from diagnostic testing and history of exposure.
  • A false negative result may occur due to inadequate sample collection, storage, and/or handling, therefore, a negative test result does not eliminate the possibility of SARS-CoV-2 infection.
  • When self-swabbing is required, it can be difficult to ensure that a sufficient sample has been obtained. It is important to follow the instructions for use carefully.
  • Some tests may not have been evaluated for use in asymptomatic individuals (i.e. individuals without signs and symptoms of respiratory infection). The test performance may differ in these individuals.
  • The IFU may specify that the test must be used within a number of days post onset of symptoms.
  • The predictive value of the test (probability of a given result being a true result) depends on the prevalence of the disease.

The HPRA has not prohibited the sale or purchase of legitimately CE marked COVID-19 test kits on the market in Ireland, but is highlighting the importance of understanding the limitations of certain test kits.

Reporting of Incidents

The HPRA strongly encourages those who have experienced a safety issue with a medical device to report that issue to us. We currently operate a voluntary reporting system for users of medical devices, healthcare professionals or any other person who identifies a medical device safety issue.

Issues or concerns about a medical device can be submitted through the HPRA's online reporting system or by downloading and completing our incident report form. Users may also report medical device safety issues to the HPRA by email ( or by telephone (01 676 4971).

Increased levels of reporting from healthcare professionals and other device users may help in the early detection of adverse trends or safety issues.

Genetic Variants-Notice to Manufacturers

This notice is addressed to manufacturers of in vitro diagnostic medical devices (IVDs) with the intended purpose to detect and/or quantify markers of SARS-CoV-2, as well as their authorised representatives. The notice underlines the manufacturers' responsibilities to continually assess the impact of newly identified genetic variants of SARS-CoV-2 on the capability of those IVDs to meet their performance, risk and safety claims.

Regulatory Information

Please visit the regulatory section of this website for further information on the regulatory framework for in-vitro diagnostics (IVDs) including information on key changes with the entry into force of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).

Links to useful publications