The Medical Device Coordination Group (MDCG), an advisory body of the European Commission (EC), focused on further improvement of medical device regulations, has developed a guidance document dedicated to the state of the art rapid antibody tests intended for use in the context of the Coronavirus Disease 2019 (COVID-19) caused by the virus SARS-CoV-2 or the “novel coronavirus”.
It is important to mention that the document does not reflect the official position of the EC with regard to the matter. It also does not introduce any obligations for the parties involved. Due to its legal nature, the provisions of the present MDCG guidance should be considered by the national regulating authorities and legislators when developing their own regulatory approach. Usually, the provisions of MDCG guidance documents are used as a basis for national and union-wide regulations on medical devices.
Regulatory Background
The MDCG states that further expansion of COVID-19 resulted in the active development of in vitro diagnostic medical devices used in the context thereof. Numerous rapid tests intended to detect antibodies were placed on the market and made available for healthcare professionals. It is important to determine the approach to be applied when evaluating the actual performance of such tests.
Nowadays the rapid tests are subject to regulation under the Directive 98/79/EC on in vitro diagnostic medical devices. According to the aforementioned Directive, the devices must be designed and manufactured in such a way that they are suitable for the intended purpose specified by the manufacturer, taking into account the generally acknowledged state of the art. Thus, the medical device manufacturer shall demonstrate that the device in question fits the intended purpose indicated by the manufacturer in the context of the state of the art. The present guidance is intended to assist in outlining the concept of the current state of the art for rapid tests. Hence, it should be used as a reference point in order to provide an understanding of the current state of the art.
According to the document, the state of the art is the developed stage of current technical capability and/or accepted clinical practice with regard to products, processes and patient management, based on the relevant consolidated findings of science, technology and experience. The MDCG also emphasizes that the concept of the state of the art covers something that is currently and generally accepted as good practice in technology and medicine, while it is not always the most advanced solution from the technological perspective. In other words, the state of the art refers to widely acceptable and achievable solutions.
The MDCG additionally mentions that the “current state of the art” could be subject to change due to improvement. Hence, the present document describes the state of the art as of the date it was published. Moreover, it could be subject to changes reasonably necessary to reflect the further improvement in technologies and regulations. The present MDCG guidance should not be treated as exhaustive or as covering all aspects of the COVID-19 rapid antibody tests. For instance, some general aspects related to all in vitro diagnostic medical devices fall outside the scope of the present guidance. Thus, the interested parties shall also consider the provisions of the Directive.
Rapid Test in Detail
First, it is important to mention that in accordance with the Commission Decision 2002/364/EC on common specifications for in vitro diagnostic devices, rapid tests are defined as qualitative or semi-qualitative in vitro diagnostic medical devices, used singly or in a small series, which involve non-automated procedures and have been designed to give a fast result.
As mentioned before, the intended purpose of a medical device is vitally important in the context of evaluating the medical device`s actual performance. Consequently, the medical device manufacturer shall precisely indicate the intended purpose of its product. Furthermore, the medical device manufacturer shall also consider the current state of the art, and adjust the intended purpose of a medical device and update the performance data when it is reasonably necessary in light of new information. The medical device manufacturer shall ensure continuous conformity of a medical device with the regulatory requirements set forth by the aforementioned Directive.
Regulatory Requirements
The present MDCG guidance also provides an overview of the regulatory requirements regarding the performance of a medical device set forth under Directive 98/79/EC. According to the Directive, the aspects to be considered include, inter alia, the following ones:
- Analytical sensitivity
- Diagnostic sensitivity
- Analytical specificity
- Diagnostic specificity
- Accuracy
- Repeatability
- Reproducibility
- Limits of detection
It is also states that the intended purpose of a medical device should be clearly indicated in the instructions for use accompanying the medical device and/or its label. The MDCG emphasizes that in the case of COVID-19 rapid antigen tests, the indication of the intended purpose should be complete and precise, and should cover the following aspects:
- The intended user
- The target population
- Window between infection and antibody detection
- Result interpretation (including limitations of interpretation)
- Assay design (target antigen(s), antibody types)
- Limitations of the assay
- Whether the assay is intended, for example, to detect the antibody response in individual patients` recovery, to assess if the patient has been previously infected, to assess response to vaccination
- The exclusion of antibody test use as first line test for diagnosis
All the aforementioned aspects should be covered by the instructions for use supplied with the device. Additionally, the technical documentation shall contain performance evaluation data sufficient to demonstrate the performance indicated by the medical device manufacturer. For this purpose, the manufacturer shall provide data derived from clinical trials or other studies conducted in an environment in which the device itself is intended to be used. Any and all study conditions should be the same as the conditions in which the rapid tests would be used in order to ensure that the performance data deriving from such studies reflect the actual performance of a medical device when used for the intended purpose.
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Sources:
https://ec.europa.eu/health/sites/health/files/md_sector/docs/mdcg_2021-2_en.pdf
