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 context of this database
The Communication from the Commission “Guidelines on in vitro diagnostic tests and their performance”, adopted and published on 15 April, 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 database is in development and its structure and layout are subject to change. In particular, information on publicly available results of validation studies and on publications by national health technology assessment bodies and the European Network for Health Technology Assessment (EUnetHTA) is envisaged to be included.
How the content 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.
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-IVD mark. 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 online accessible 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.
The so-called in-house or laboratory developed devices are used in healthcare institutions but are not commercially available (see next section). They are not included in the list of devices, as they are not easily identifiable by name, but scientific publications on such devices and related test methods are included in the section ‘Scientific literature’.
The link to the legal framework for placing devices on the EU market
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.