Anyone wanting to either keep a DiGA in the directory or have one newly listed since January 1, 2025 needs the certificate under BSI TR-03161.
The extended grace period for manufacturers to submit it now ends on June 30. The big question: what happens to those DiGA that cannot present a certificate by then?
What manufacturers specifically need to bear in mind now:
Listed DiGA
DiGA currently listed will remain in the directory for now. As things stand today, it has not yet been determined when those DiGA will have to present the certificate.
DiGA applications under substantive review
a) If the substantive review period for your DiGA has not yet expired, the procedure continues and the BSI certificate must be presented before the review deadline expires.
b) If the review period of up to six months has expired and no BSI certificate can be presented, you must withdraw the DiGA application, otherwise it risks being rejected. The reason: the BfArM gives no guarantees here that it will continue to review the DiGA if the certificate is not available. In other words, when a DiGA is resubmitted, new deficiencies may be found and the process could drag on further.
DiGA to be newly submitted from July 1, 2025 and DiGA under formal review
The certificate must be presented at the end of your formal review.
DiGA in appeal proceedings
In this case you need the certificate immediately, provided the appeal was successful.