In line with Article 168(1) and (2), a high level of human health protection shall be ensured in the definition and implementation of all Union policies and activities. Union action shall cover, amongst other, monitoring, early warning of and combating serious cross-border threats to health, and shall encourage cooperation between the Member States in this area and, if necessary, lend support to their action.
(2)
In line with Article 168(7) of the Treaty on the Functioning of the European Union, Union action shall respect the responsibilities of the Member States for the definition of their health policy and for the organisation and delivery of health services and medical care. EU Member States are thus responsible for deciding on the development and implementation of COVID-19 testing strategies, including the use of rapid antigen tests, taking into consideration countries’ epidemiological and social situations as well as the target population for testing.
(3)
On 15 April, the Commission adopted Guidelines on COVID-19 in vitro diagnostic tests and their performance (1), providing considerations on test performance and recommending that COVID-19 tests be validated prior to introducing them into the clinical routine.
(4)
On 15 July, the Commission adopted a Communication on short-term EU health preparedness for COVID-19 outbreaks (2), which, among other measures to reinforce preparedness and coordinated response capacities, identified testing as one of the main action areas to be addressed by Member States, and which set out specific key measures to be taken in the next months.
(5)
On 28 October, the Commission adopted a Recommendation on COVID-19 testing strategies, including the use of rapid antigen tests (3). The Recommendation set out guidance for countries regarding key elements to be considered for their COVID-19 testing strategies, and considerations for the use of rapid antigen tests were also put forward.
(6)
On 18 November, the Commission adopted a Recommendation on the use of rapid antigen tests for the diagnosis of SARS-CoV-2 infection (4), further specifying the criteria to be used for the selection of rapid antigen tests, the settings during which rapid antigen tests are appropriate to be used, test operators, validation and mutual recognition of rapid antigen tests and their results. While cheaper and faster, rapid antigen tests have generally a lower test sensitivity than RT-PCR.
(7)
The currently applicable regulatory framework for placing rapid antigen tests on the market is Directive 98/79/EC (5). According to the Directive, for SARS-CoV-2 rapid antigen tests, the manufacturer must draw up a technical file which explicitly shows that the test is safe and performs as intended by the manufacturer, by demonstrating compliance with the requirements laid down in Annex I of the Directive.
(8)
From 26 May 2022, Directive 98/79/EC will be replaced by Regulation (EU) 2017/746 on in vitro diagnostic medical devices (6). Under the Regulation, rapid antigen tests will be subject to reinforced requirements on device performance and a thorough assessment by a notified body. This may reduce the additional effort required for the validation of these tests prior to their use as part of national strategies.
(9)
Effective testing contributes to the smooth functioning of the Internal Market as it allows for targeted isolation or quarantine measures. Mutual recognition of test results for SARS-CoV-2 infection carried out in other Member States by certified health bodies, as provided for in point 18 of Council Recommendation (EU) 2020/1475 (7), is essential in order to facilitate cross-border movement, cross-border contact tracing and treatment.
(10)
Given the requirement for EU candidate countries and EU potential candidate countries as well as for countries that have concluded with the EU agreements establishing a deep and comprehensive free trade area (DCFTA countries) to align to the EU acquis where applicable, and the participation of some of these countries in EU joint procurement for relevant products, this proposal for a Council Recommendation may also be of interest to these countries.
