The objective of the JRC COVID-19 In Vitro Diagnostic Devices and Test Methods Database is to collect in a single place all publicly available information on performance of CE-marked in vitro diagnostic medical devices (IVDs) as well as in-house laboratory-developed devices and related test methods for COVID-19.
The database is in continuous development and its structure and layout are subject to change.
On the database
COVID-19 in vitro diagnostic medical devices
This section of the database contains publicly available information on in vitro diagnostic medical devices for COVID-19 and it is being updated periodically. Please note that the content is based on publicly available information mostly provided by manufacturers. Additional performance (as independently retrieved from manufacturers’ web pages) is provided only for devices commercially available with CE-mark.
The conformity of the devices with applicable EU law has NOT been in any way assessed by the European Commission or Member State national authorities for the purposes of inclusion in the database. 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. For more information see The link to the legal framework for placing devices on the EU market.
For rapid antigen tests, as part of the EU Health Security Committee (HSC), the Member States have agreed on a common list of these tests considered appropriate for use in the context of COVID-19 diagnosis, as well as a selection of these whose results should be mutually recognised. For more details see Health Security Committee agreement on rapid antigen tests (RAT)
How the content of this section of the database is generated
The information presented here is gathered following the strategy for Documentation on test methods and devices indicated in Section 3 of the Working document of Commission services Current performance of COVID-19 test methods and devices and proposed performance criteria, of 16 April 2020.
For CE-marked devices, only the information that the manufacturer has chosen to make publicly available is included in this database. Full information on the manufacturer’s performance evaluation of the device is contained in the technical documentation required by the EU legislation. Manufacturer technical documentation is usually not publicly available and is therefore not included here.
Performance details (as retrieved from manufacturers’ web pages) is provided only for devices commercially available with CE-marking. Products labelled as for ‘research use only’ or ‘under development’ as well as products fulfilling other regulatory frameworks than the EU legislation are listed for information only. The correctness of information, such as listed performance data of the devices, has not been confirmed by checking raw experimental data or full technical documentation of the manufacturer which is not accessible online or by own laboratory verification or by any clinical validation studies. Therefore, the JRC should not be deemed responsible for the validity of such data.
Considering the rapidly evolving situation in relation to the development and commercialisation of diagnostic devices for COVID-19, the completeness of the information is limited to the time of the last update as indicated in the database for each item.
Manufacturers are invited to submit performance information on new devices, which are not yet listed, or to provide data not available to the authors at the time of the last update. The submitted information, once verified against the source provider, will be taken into consideration for updating the database.
Scientific literature on COVID-19 test methods and devices
This section of the database contains selected scientific articles reporting about the use and performances of devices and related test methods for COVID-19 diagnostics.
A team of JRC experts regularly takes care of updating the scientific literature on COVID-19 test methods and devices section. A key feature in the database is the interconnection that links each scientific article to the corresponding devices assessed and, vice versa, the devices, and their features, to scientific articles that reported their use and performance. This allows a clear, transparent and fully open data source where users can look at and make the right choice in the selection of the device or method to use.
This section regards also the so-called in house1 or laboratory developed devices, which are used in healthcare institutions but are not commercially available. These are not included in the list of COVID-19 in vitro diagnostic medical devices, but scientific publications on such devices and related test methods are included in the section.
1 The in house devices are those referred to in Art.1(5) of Directive 98/79/EC: “devices manufactured and used only within the same health institution and on the premises of their manufacture or used on premises in the immediate vicinity without having been transferred to another legal entity”. They are exempt from requirements of Directive 98/79/EC but may be subject to national law.
EUnetHTA publications repository
EUnetHTA (European network for Health Technology Assessment) Joint Action 3 is the scientific and technical component of EU cooperation on HTA. EUnetHTA developed a COVID-19 related repository of publications and outputs produced jointly or by individual HTA organisations on testing methods and devices for SARS-CoV-2.
This section of the database points to the repository of EUnetHTA publications on testing methods and devices for SARS-CoV-2, with information on publicly available results of validation studies and on publications by national health technology assessment (HTA) bodies and the European Network for Health Technology Assessment EUnetHTA .
SARS-CoV-2 NAAT target regions
Tool to assess if SARS-CoV-2 genomic variations can affect detectability of the target regions by nucleic acid amplification tests (NAAT) methods. This section is an inventory of PCR-based NAATs mostly used by laboratories (WHO recommended) and in silico simulations of these assays on available high quality and full length sequenced SARS-CoV-2 genomes (in collaboration with GISAID).
Pre-computed values, corresponding to the extent of matching of the primers and probes from NAAT database methods against high quality, full-length genomic sequences, allow to detect potential target regions of the NAAT methods and to highlight possible differences with the expected reference sequence, which might affect the NAAT performance.
The information is retrieved and updated periodically.
Explore the data
This section allows surfing in and mining of data and analyses performed on SARS-CoV-2 sequences, like phylodynamics of hCoV-19 in EU27, which allows tracking of pathogens evolution data of the coronavirus disease 2019 (hCoV-19) pandemic in the European Union countries.
The context of the database
The Communication from the Commission “Guidelines on in vitro diagnostic tests and their performance”, adopted and published on 15 April 2020, states the following under Further actions needed: “The Commission, supported by the ECDC, health technology assessment experts and in vitro diagnostics competent authorities, will assist Member States with a centralised overview of available information on test performance and act as a single point of contact for management of this information. Taking stock of the state of the art on a regular basis will support Member States’ informed decisions on national testing strategies, as well as support the continuous development of devices by manufacturers.”
As an initial step in collecting information on performance of devices and in-house methods, to address the above need, the European Commission published a Working document of Commission services Current performance of COVID-19 test methods and devices and proposed performance criteria, on 16 April 2020.
The Working document had been produced by European Commission services (DG SANTE, DG JRC, DG RTD), by the European Centre for Disease Prevention and Control (ECDC) and by several experts from in vitro diagnostics competent authorities and health technology assessment. The JRC capitalised on its expertise in knowledge management to conduct the literature review as part of this work.
Following the publication of the Working document, and as a follow-up action to the need identified in the Communication, the JRC has committed to make the information broadly accessible and to update the compilation as new data become available. This website has been developed by the JRC for this purpose.
The link to the legal framework for placing devices on the EU market
The section ‘COVID-19 in vitro diagnostic medical devices’ of this database does NOT represent a list of devices approved or authorised for use either by the European Commission or by Member State national authorities. There is no central approval system for in vitro diagnostic medical devices in the EU.
The currently applicable legislation for placing COVID-19 diagnostic devices on the market in the EU is Directive 98/79/EC on in vitro diagnostic medical devices.
Under the Directive, for COVID-19 devices that are designed for professional use, the manufacturer may affix the CE-mark to the product after having ensured the compliance of the device with the Directive and drawn up a declaration of conformity. For COVID-19 devices that are designed for use by lay persons (self-tests), the manufacturer must also apply to a third party body called a notified body who will do additional verification and issue a certificate.
The in-house devices are those referred to in Article 1(5) of the Directive: “devices manufactured and used only within the same health institution and on the premises of their manufacture or used on premises in the immediate vicinity without having been transferred to another legal entity”. They are exempt from the Directive’s requirements but may be subject to national law.
From 26 May 2022, the Directive will be replaced by Regulation (EU) 2017/746 on in vitro diagnostic medical devices. However, the Regulation lays down a transitional period starting on the date of its entry into force (May 2017) during which the conformity of in vitro diagnostic medical devices can be assessed either under the Regulation or under the Directive.
More information on the regulatory framework, together with a number of guidance documents, may be found on the Commission’s dedicated medical devices website. Please see also the Q&A on in vitro diagnostic medical device conformity assessment and performance in the context of COVID-19, available on the guidance page of the Commission’s medical devices website.
Health Security Committee agreement on rapid antigen tests (RATs)
On 21 January 2021, EU Member States unanimously agreed on a Council Recommendation setting a common framework for the use of rapid antigen tests and the mutual recognition of COVID-19 test results across the EU. Key components of this recommendation include the development of a common list of COVID-19 rapid antigen tests (RAT) and a selection of these tests for which Member States would mutually recognise the test results for public health measures.
More specifically, it was agreed that EU Member States should agree on, maintain and share a common and updated list of COVID-19 rapid antigen tests that are considered appropriate for use in the context of the situations described under point 6 of the Council Recommendation and that are in line with countries’ testing strategies.
The rapid antigen tests included in the common list should: (a) Carry CE marking; (b) Meet the minimum performance requirements of ≥ 90% sensitivity and ≥ 97% specificity. (c) Have been validated by at least one Member State as being appropriate for their use in the context of COVID-19, providing details on the methodology and results of such studies.
The Council Recommendation and the criteria described within formed the basis for the development of the Health Security Committee (HSC) document (published on 17 February 2021 and regularly updated) containing the latest version of the common list of rapid antigen tests.
The common list of rapid antigen tests is regularly being reviewed by Member States in the context of Health Security Committee meetings, and, if necessary, be updated in line with new results from independent validation studies becoming available and new tests entering the market.
In case certain tests are not included in the list, this is because they either did not meet the criteria as agreed by the Member States or because the relevant data and information was not available at the time when the HSC discussed the common list.
On 10 May 2021, the Health Security Committee agreed to update the common list of COVID-19 rapid antigen tests (RATs), including those whose results are mutually recognised by EU Member States. On 7th July the Health Security Committee agreed that the entire common list is considered to consist of rapid antigen tests of which Member States mutually recognise the test results for public health measures.
The common list of rapid antigen tests only includes rapid antigen tests for which their clinical performance was measured based on samples collected from nasal, oropharyngeal or nasopharyngeal specimens and that are conducted by trained healthcare personnel or trained operators where appropriate (in line with Commission Recommendation (EU) 2020/1743 of 18 November 2020). Rapid antigen tests that are based on other samples, such as saliva, sputum and/or faeces, and rapid antigen self-tests are not included.
Following Member States decision and Health Security Committee (HSC) agreement, the Joint Research Centre (JRC) is updating its COVID-19 In Vitro Diagnostic Medical Devices database to incorporate also the common list of rapid antigen tests in this online resource.
On the on 7th July 2021, the HSC agreed that also laboratory-based antigenic assays (e.g. enzyme immunoassays such as ELISA or automated tests) should be included in the EU common list, so it is possible for manufacturers and countries to put forward proposals for lab-based antigenic assays for inclusion in the list.
In addition, the Commission and the Joint Research Centre agreed in April 2021 on a new procedure for updating the RAT common list, which includes the possibility for manufacturers to submit information and data on RATs to be reviewed by the HSC for possible inclusion in the common list. On the 7th July the JRC implemented a procedure also for the submission of information and data on lab-based antigen tests to be reviewed by the HSC for possible inclusion in the common list
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. The document agreed by the HSC should therefore be considered as guidance and is not of binding nature.
For more information on the evaluation process for inclusion in the common list, background documentation and relevant contacts see the Technical working group on COVID-19 diagnostic tests
For more information on the COVID-19 In Vitro Diagnostic Devices and Test Methods Database, see: "The EU one-stop-shop collection of publicly available information on COVID-19 in vitro diagnostic medical devices". F1000Research 2020, 9:1296.