The European Commission (EC), the EU body responsible for medical device regulations, has published a Q&A document dedicated to in vitro diagnostic medical device conformity assessment and performance in the context of COVID-19. The guidance is intended to provide medical device manufacturers and other parties involved with the additional clarifications and recommendations to be considered in order to achieve and sustain compliance with the applicable regulatory requirements set forth under the EU legislation.
The document provides the definitions of the most important terms used in the context of the aspects addressed therein. These terms include, inter alia, the following ones:
- Authorized representative – an organization that legally represents a manufacturer in the EU, when the manufacturer is based outside the EU;
- Distributor – a natural or legal person making devices available in the Union, other than the manufacturer or the importer;
- Notified body – an organization that issues certificates to manufacturers, demonstrating that the manufacturer has fulfilled certain legal requirements;
- Self-test – a device intended by the manufacturer to be used by laypersons in a home environment.
The present EC guidance is mostly dedicated to COVID-19 tests – the in vitro diagnostic medical devices intended to be used in the context of the current outbreak of the Coronavirus Disease 2019 (COVID-19) caused by the virus SARS-CoV-2 or the “novel coronavirus”.
The EC additionally emphasizes that the present guidance describes the processes and procedures related to placing IVD tests on the EU market under the In Vitro Diagnostic Medical Devices Directive 98/79/EC (Directive), and not the In Vitro Diagnostic Medical Devices Regulation 2017/746 which should enter into force later in May 2022 and replace the aforementioned Directive.
COVID-19 Tests in Detail
According to the guidance, the most common types of COVID-19 tests used nowadays are the following ones:
- The tests detecting the presence of the virus itself (RT-PCR tests or antigen tests detecting the viral protein), and
- The tests detecting the immune response of the human body (antibody tests).
Thus, the main distinguishing criterion to be applied is the principal mode of action.
As it is stated in the document, the COVID-19 tests could be also classified by:
- Intended user (healthcare professional vs lay user, the latter are termed self-tests);
- Type of technology (automated, manual, or rapid tests which are non-automated and designed to give a fast result);
- Location of testing (sent off to a laboratory or performed near the patient, the latter also referred to as point-of-care tests).
In terms of COVID-19 tests classification, the EC also refers to the appropriate Communication issued earlier by the EC – the Guidelines on COVID-19 in vitro diagnostic tests and their performance.
According to the applicable legislation, the tests intended to be used for medical purposes are deemed to be in vitro diagnostic medical devices and should be treated accordingly. In particular, these products should be manufactured and marketed in accordance with the regulatory requirements set forth under the appropriate Directive. They also should have a CE marking confirming that the medical device complies with the applicable regulatory requirements and is allowed to be placed on the EU market. At the same time, some of the tests are conducted directly with the patient – for example, a computerized tomography scan. The medical devices to be used in such cases are not in vitro diagnostic medical devices (the latter are intended to be used solely for the purpose of examination of the specimens without direct contact with the patient), thus the regulatory requirements applicable thereto are falling outside the scope of the present guidance.
Another important concept describes in the present EC guidance is the in-house tests which are the in vitro diagnostic medical devices manufactured by the healthcare institution (laboratory) and intended to be used solely for internal purposes of that entity. The transfer of such tests to other entities is strictly prohibited since this would be deemed as marketing, which requires the appropriate authorization prescribed by the applicable regulatory requirements. Due to the fact that such COVID-19 tests are not intended to be placed on the market and made broadly available, they are not subject to regulation under the IVDD. However, the in-house in vitro diagnostic medical devices still should comply with the applicable regulatory requirements set forth by the national legislation of the country the healthcare institution (laboratory) is located in.
The EC also mentions that the in vitro diagnostic medical devices intended to be used for research purposes only are also exempted from regulation under the IVDD since such medical devices have no intended medical purpose. These tests could be used for general scientific purposes, while it is not allowed to use them in the context of the actual decision-making process when the patient is involved. In the case of such tests, their intended purpose should be clearly indicated by the medical device manufacturer, while the instructions for use should not contain any references to use for medical purposes as described above.
According to the document, there is no centralized database containing complete and exhaustive information on any and all COVID-19 tests placed on the market. There are several databases containing information about the in vitro diagnostic medical devices covered by the scope of the present guidance, but none of them should be treated as the one complete.
Placing COVID-19 Tests on the EU Market
In order to assist medical device manufacturers and other parties involved in operations with COVID-19 tests, the present EC guidance provides an overview of the processes and procedures to be performed under the applicable regulatory requirements when placing such medical devices on the market.
As was already mentioned before, all in vitro diagnostic devices intended to be used for medical purposes should be CE-marked. Thus, affixing the CE mark is a mandatory step to be performed. In order to be allowed to perform this, the medical device manufacturer shall duly demonstrate that the in vitro diagnostic medical device in question complies with the applicable regulatory requirements. The manufacturer shall also have all documentation necessary to demonstrate such compliance in terms of safety and effectiveness of the medical device it is going to place on the market, including such elements as:
- A general description of the product,
- The documentation of the quality system,
- Detailed design information,
- The results of risk analysis,
- Adequate performance evaluation data,
- Stability studies,
- Instructions for use, and
- Other documents that could be reasonably necessary to demonstrate such compliance.
Moreover, the medical device manufacturer is obliged to implement and follow the appropriate conformity assessment procedures.
Summarizing the information provided here above, the present EC guidance describes in detail the most important regulatory aspects related to placing in vitro diagnostic medical devices on the market, including the applicable regulatory requirements the COVID-19 tests should meet, as well as the procedures to be followed. The document also provides an overview of the current legislation introduced on the union-wide level.
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