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07 April 2021
Besides vaccination, one of the most important measures to counter the COVID-19 pandemic is to test people for the virus and order them to quarantine if necessary. In Germany, tests for specific diseases such as COVID-19 may normally be handled only by medical professionals under the Ordinance Regulating the Dispensing of Medical Products (MPAV). Among other reasons, this is to ensure proper traceability of infections since professional users must inform the authorities of positive tests. However, given the need to test laypeople (eg, when visiting family or friends), the legislature has amended the MPAV to enable such tests to be dispensed by laypeople as well.
As COVID-19 tests for laypeople constitute in vitro diagnostics (ie, medical devices), they are regulated by the Medical Devices Act (MPG), which implements EU Directive 98/79/EC on in vitro diagnostics. Under the MPG, COVID-19 tests for laypeople must undergo a conformity assessment procedure that involves a notified body. However, since such procedures take a significant amount of time and the MPAV amendment is relatively new, it is unsurprising that many manufacturers are yet to complete them.
The MPG provides that under specific exceptional authorisation conditions, medical devices may be placed on the market even where the required conformity assessment procedure is incomplete. The main prerequisite of an exceptional authorisation is that the use of the product must be for the protection of health.
Section 11(1) of the MPG states as follows:
By way of derogation from the provisions contained in Sec. 6 para. 1 and 2 (conformity assessment procedure and subsequent CE marking), the competent higher federal authority may authorise for a limited period of time, on duly justified application, the first placing on the market or putting into service in Germany, of individual medical devices for which the procedures according to the ordinance pursuant to Sec. 37 para. 1 (Ordinance on Medical Devices and Conformity Assessments) have not been carried out, provided their use is in the interest of the protection of health.
The Federal Institute for Medicinal Products and Medical Devices (BfArM) – the competent authority under Section 11(1) of the MPG – has published guidance on exceptional authorisations for COVID-19 tests for laypeople.
To obtain an exceptional authorisation, manufacturers must apply in writing. Applications must include:
Exceptional authorisations are valid for a limited period (eg, three months) but can be extended via a further application. The BfArM examines applications strictly to determine whether they meet the exceptional authorisation conditions. However, several tests have already passed such examination and can therefore be used by laypeople in circumstances where, for example:
For further information on this topic please contact Caroline von Nussbaum or Fabian Huber at Simmons & Simmons LLP by telephone (+49 2 11 4 70 53 0) or email (firstname.lastname@example.org or email@example.com). The Simmons & Simmons LLP website can be accessed at www.simmons-simmons.com.
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