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 devices@hpra.ie.

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

Genrui SARS-CoV-2 Antigen Self-Test

On 18 January 2022, the HPRA issued a safety notice to raise awareness of a product recall of two batches of the Genrui SARS-CoV-2 Rapid Antigen Self-Test. This recall action follows on from the voluntary suspension from sale of the Genrui self-test by retailers in Ireland on 5 January. For more information, please see the HPRA news item, which contains updates from 18 January and 5 January, and the safety notice, which was published on 18 January. 

Due to high volumes of reports, individuals who report to the HPRA may not receive a response directly and relevant updates will be published on our website. Individuals/users can report incidents with antigen tests or any other medical devices via the HPRA online reporting form.

Rapid Antigen Test

Rapid antigen tests differ depending on the intended purpose specified by the manufacturer. The intended purpose can include factors such as the setting in which the device is used, the intended user, the technology, the sample type and any others as specified by the manufacturer. Generally rapid antigen tests are either intended by the manufacturer to be used;

  • in a professional setting by competently training professionals; or
  • in the home environment by lay persons, also referred to as devices for self-testing.

You should check the labelling and instructions for use to determine the intended purpose of a rapid antigen test. If the test is designed and marketed by the manufacturer for use by professionals, it is not intended to be sold to members of the public for self-testing purposes. Rapid antigen tests intended for self-testing are required to undergo an independent assessment by a notified body on the suitability of the device design and instructions for lay persons. For this reason, these devices are suitable to be sold to members of the public.

There are a number of other checks to determine whether or not a rapid antigen test appears to conform to the current regulatory requirements. You should start by examining the device and its label for the following;

  • Make sure the device bears a CE mark.
  • If the device is intended for self-testing, that fact must be clearly stated either on label or on the instructions for use.
  • As well as the CE mark, self-test devices must also have a four-digit notified body number displayed close to the CE mark. Devices not intended for self-test have a CE mark with no number displayed.


Self-tests have a CE logo and 4-digit Notified Body Number

  • Make sure the device information is provided in the English language.
  • For retailers, including pharmacies, verify with your supplier that the device has a valid declaration of conformity
  • For retailers, including pharmacies in the case of self-tests, verify with your supplier that the device has a valid EC design-examination certificate from an EU-27 entity.
  • Check that the manufacturer’s contact details are visible on the device label and instructions for use.
  • Where the device manufacturer is located outside of the EU (including the United Kingdom), check that the name and address of the European point of contact, known as the authorised representative, is visible on the label and instructions for use.

You should check the HSE website for the latest public health advice and instructional videos on the use of rapid antigen tests for COVID-19.

Once a rapid antigen test is in conformity with the IVDD and is CE marked, it can be freely placed on the market. There is no requirement for a distributor or importer to be authorised or licensed by the HPRA in order to sell rapid antigen tests

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 provided by the manufacturer. When performing any test, the user is advised to read the instructions for use prior to use. The user should first determine if the test is to be used in a professional setting only   if it can be used as a self-test in a home setting. 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 instructions for use may affect test performance and impact the validity of the test result.
  • 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.
  • The predictive value of the test (probability of a given result being a true result) depends on the prevalence of the disease.

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 (devices@hpra.ie) 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 Framework for In-Vitro Diagnostic Devices (IVDs)

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