Alan Dillon (Mayo, Fine Gael)
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2670. To ask the Minister for Health if he will provide the list of companies that manufacture and supply SARS-CoV-2 antigen rapid test kits to Ireland that are fully in compliance with EU regulations and requirements and are authorised for personal use or commercial sale in Ireland; and if he will make a statement on the matter. [38736/21]

Stephen Donnelly (Wicklow, Fianna Fail)
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Tests for COVID-19 are regulated under the European In-Vitro Diagnostics Directive (IVDD, Directive 98/79/EC) and must be CE marked before being placed on the market in Ireland or elsewhere in the EU. A CE mark is a declaration that the product complies with the requirements of the relevant European legislation. Any manufacturer can apply a CE mark if they meet the relevant requirements. However, depending on the legislation and class of the device, an external and impartial organisation may be required to independently assess if the manufacturer has met these requirements. This is known as ‘conformity assessment’ and for Medical Devices and IVDs an organisation that performs conformity assessment in Europe is known as a Notified Body.

The National Standards Authority of Ireland is a Notified Body for Medical Devices and IVDs (In-Vitro Diagnostics) in Ireland. It is important to note that in terms of intended use, a rapid antigen detection test (RADT) may be designed by the manufacturer to be used by health care professionals or by lay users. COVID-19 tests which are indicated for use by healthcare professionals are classified as General IVDs and are often referred to as ‘self-declare’. This means that they do not require involvement by a Notified Body regarding conformity assessment. Instead, the manufacturer ‘self-declares’ their conformity to the essential requirements within the IVDD. COVID-19 tests which are indicated for use by lay persons (not medical professionals) are classified as Self-Test. This means they do require Notified Body involvement to assess conformity to the applicable regulatory requirements.

The 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. 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. The Department of Health does not maintain a list of tests that have been CE marked or that are available on the Irish market.

A list of COVID-19 tests available in the EU can be found in the COVID-19 In Vitro Diagnostic Devices and Test Methods Database at covid-19-diagnostics.jrc.ec.europa.eu. However, it should be noted that there is no central approval system for in vitro diagnostic medical devices in the EU and the database does NOT represent a list of authorised or approved devices in the European Union.

Considerable work has been undertaken to date to evaluate the potential use of rapid antigen detection tests (RADTs) in an Irish context and this will continue on an ongoing basis. In the health sector, the HSE has deployed rapid antigen tests for use for specific indications in the acute hospital setting, and as part of the response to outbreaks in the community setting, supported by appropriate clinical governance and operational arrangements. This includes updating the case definition for SARS-CoV-2 to accept notification of positive results from rapid antigen tests undertaken in the public health system and reporting of such cases to the COVID Care tracker and to the Computerised Infectious Disease Reporting (CIDR) information system developed to manage the surveillance and control of infectious diseases in Ireland. The current position of the HSE is to use rapid antigen tests only in settings where there is a CE marked, validated assay for use and where an appropriate clinical care pathway is in place to manage the current limitations of the test.

The HSE has recently published the report of the Antigen Test Validation Project which validated a number of rapid antigen detection tests (ADTS) intended for testing samples for SARS-CoV-2 antigen. The products evaluated were chosen as those expected to represent the best available products based on the manufacturers claims and other available evidence. The recommendations in this report will assist in the consideration of other potential applications of rapid antigen detection tests in the health service to support the overall national testing strategy.

I have established an Expert Advisory Group on Rapid Testing which will be chaired by Professor Mary Horgan, to support and advise Government departments who are responsible for progressing pilots and the rollout of rapid tests to their respective sectors.

On an ongoing basis, the National Public Health Emergency Team considers and reviews how best to target testing to detect, and mitigate the impact of, the virus across the population. This includes keeping Ireland’s national testing and tracing policy under continuing review.