It is commonly known that COVID-19 IVD tests may be CE marked under annex III of the IVD Directive without the involvement of a Notified Body.
To nonetheless increase supervision, competent authorities in Germany have implemented routines with additional review mechanisms.
In addition to the guidance on performance evaluations for COVID-19 IVD that has been published earlier this year (see recommended articles below), the German Federal Institute of Vaccines and Biomedicines has issued their perspective on performance criteria test systems related to rapid SARS CoV 2 antigen tests should fulfill (link further down).
It is highly recommendable to use these reference values when reviewing the corresponding technical documentation to make sure that reimbursement in Germany is provided for.
To receive further information on this subject, please notice the following articles and links
- German Federal Institute of Vaccines and Biomedicines performance criteria
- COVID-19 In Vitro Diagnostic Devices and Test Methods Database available
- Surgical and FFP masks in the COVID-19 crisis
- European Commission gives details of how to prevent COVID-19 test failures
- Guidance on MD and PPE in times of COVID-19 and local provisions