Your path to class I

In order to ensure the marketability of health apps and other digital medicine products within the EU in the future, licensing as a medical device has become practically inevitable. Through close cooperation with the Bundesverband für Internetmedizin (BiM) and the responsible supervisory authorities, has already been able to gain extensive experience in this area, from which you can now benefit. Together with our partners, guides you safely and purposefully through the process of self-certification.

Step 1: product analysis

Products without systemic risks, which do not provide inrofrmation for diagnosis or therapy, are generally assigned tp risk class I. This classification is based on the regulations of the medical device law and thus in future particular the Medical Device Regulation (MDR). We analyze your product and show you possibilities hpw tp üpsition yoour product in the best possible way within legal framework.

Step2: certification support

Auf Grundlage der abgeschlossenen Produktanalyse begleitet Sie durch den gesamten Prozess der Selbstzertifizierung von der Erstellung der Zweckbestimmung bis hin zur Anmeldung Ihres Produktes beim DIMDI. Gemeinsam mit unseren Partnern  unterstützt die Zertifizierung so umfassend, dass im Ergebnis eine nachhaltige Verkehrsfähigkeit als Medizinprodukt der Risikoklasse I gewährleistet werden kann

Step 3:BiM-seal

In cooperation with and on behalf of the Bundesverband für Internetmedizin (BiM), also offers you the opportunity to certify yourself under the seal "Quality Product Internet Medicine" issued by BiM. Set yourself apart from your competitors and demonstrate a particularly high quality standard by meeting additional requirements for the quality and safety of your product.