The Third Ordinance amending the Medical Devices Dispensing Ordinance in the Context of the Epidemic Situation of National Significance (3rd MPAVÄndG) abolished the previously existing ban on dispensing Corona rapid tests for self-testing with effect from 03.02.2021. This means that it is now legally permissible to dispense Corona rapid tests for self-testing, i.e. for use by laypersons at home.
However, this does not mean that from now on all already available Corona rapid tests can actually be dispensed to laypersons or consumers. Currently, there is still a lack of products that fulfil the corresponding specific regulatory requirements. On the one hand, there must be a specific intended use by the manufacturer for self-testing. In practice, the second prerequisite, that such rapid tests as in vitro diagnostics must have undergone a specific conformity assessment procedure, in which the special requirements for a product intended for self-testing are examined, is more burdensome. The standard procedure here is a specific conformity assessment procedure with the participation of a notified body. After completion of this conformity assessment procedure, the corresponding rapid tests for self-testing will be marketable throughout the EU. This could be achieved even more quickly by means of a special national authorisation. This will be granted for Germany by the BfArM. According to reports, numerous manufacturers have already applied for such a special authorisation. The first products that can be marketed in Germany for personal use are therefore expected in the next few weeks.
Attention: However, even with a product that can be marketed accordingly, further requirements will have to be observed: Sec. 3 para. 2 no. 3 MPAV – which was not changed by the above-mentioned 3rd Amendment Ordinance – stipulates in Germany that when dispensing these rapid tests for self-testing, the dispensing entity has to guarantee expert advice if required. This must therefore also be observed in the future.
Do you have any questions about this news or would you like to discuss the news with the author? You are welcome to contact: Dr. Florian Niermeier
