Anne Matousek
Senior Consultant QM & RA, Regulatory Affairs Expert

Tel.: 07131 2774-40

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Many people will be pleased when, in addition to vaccinations, more COVID-19 rapid tests become marketable for laypeople. The experts at seleon provide regulatory support, while M3i from Munich takes care of demonstrating the usability as required.


Rapid, usable and compliant market-release of COVID-19 rapid tests for self-administration at home.
Fast market access means fast availability for users - a task for a strong team: seleon from Heilbronn and M3i from Munich combine their expertise to support in the process of gaining approval of rapid tests for laypeople and demonstrating their usability.


In the light of current events COVID-19 antigen rapid tests for use by laypeople are currently in great demand. And there are a number of potentially useful ways in which such tests can be used to support our society in the fight against the pandemic. It is often discussed, for example, that "tests at the entrance" can be used to make large events possible, or in other risky spatial situations such as on flights and cruise ships, the safety of passengers and on-board personnel could be significantly increased. But also in the private environment or at the workplace, a purposeful use would be conceivable.

In contrast to the hitherto exclusive use of rapid tests by medically trained personnel, such as in test centres, doctors' surgeries, health offices, pharmacies, etc., "use by laypersons" means that anyone can perform such a test against COVID-19 for themselves or under guidance and obtain a result in typically fifteen to thirty minutes. The "application by laypersons" means that anyone can carry out such a test against COVID-19 for themselves or under guidance and obtain a result in typically fifteen to thirty minutes.

At the same time, however, this also means that such tests must be safe to use by the untrained layperson and must be highly effective. Legislators both nationally and at EU level are therefore placing higher demands on the regulatory processes for the approval of such rapid tests.

In the context of the tests, it is important to distinguish correctly between antibody tests that show that one was already infected with the Sars-Cov2 virus, but not whether one is currently Corona-positive. The selftests for home use should be able to prove or disprove the latter, for example to allow short-term undertakings.

Since speed also plays an important role in situations such as the current pandemic, there are various other national options for making these tests available to the population in addition to the conventional approval procedures. In particular, the procedure for special approval according to § 11, which is currently being carried out in Germany by the BfArM on the basis of the German Medical Device Law (MPG), should be mentioned. This special approval procedure already served last year to enable a sufficient supply of masks to be made available more rapidly.

Naturally, there are many solutions in this area that have been done hastily. In addition, there is a continuous need for clarification with and (currently unfortunately also) between the various national and European institutions responsible. Almost on a daily basis, new documents are published or bulletins are issued in this regard. For manufacturers or distributors of such rapid tests, who may not have been confronted with such regulatory approval procedures so far, this may appear like an invincible jungle at first sight.


So what is the main point?

  • A high "detection quality" of the test, which has already been proven and led to approval for "professional use".
  • To prove that a test already approved for professional use (point of care) also has a high level of usability for the layperson. This also includes appropriate instructions for use and adherence to the EN 62366-1 standard.
  • Professional support for all the regulatory issues that cannot be covered by the distributor. This may also include weighing up between market access via a special authorisation or a regular EU-wide authorisation process.


We do not leave the manufacturers alone.

We tackle these tasks for you in our strong team of M3i and seleon with combined forces: M3i as an established provider of comprehensive solutions for usability issues together with seleon as a proven partner in all regulatory issues. And you as a manufacturer benefit from our combined forces to make your product ready for the market, even for lay application.


Please note that all details and listings do not claim to be complete, are without guarantee and are for information purposes only.

Every product is unique – the mandatory tasks and measures for entering the market need to be specified individually. seleon advises you on your individual questions without any obligation.


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