The MindDoc App is a risk class I medical product according to the Council Directive 93/42/EEC Appendix IX.3 rule 12 (Medical Device Directive MDD)

online-therapy

Intended medical purpose:

The MindDoc monitoring and self-management application medical device provides continuous long-term sign and symptom monitoring of common mental disorders. This protocol is supplemented by courses and exercises. This enables users to recognize patterns in their symptom trajectories which then can be shared with a mental health care expert and used for self-management.
MindDoc thus:

  1. provides users orientation regarding the need to consult a mental health care provider by providing an assessment of the general emotional health. A mental health care provider then can include the summary of the protocols in his overall diagnostic and clinical assessment.
  2. enables users to self-manage symptoms and related problems by providing both transdiagnostic and disorder-specific evidence-based courses and exercises which help them to recognize, understand, and cope with signs and symptoms of mental disorders by self-initiating behavior change.

Note:

  • The application explicitly does not replace the diagnosis by a mental health care provider, but can only give orientation on whether to consult a mental health care provider who then can include the results of the medical device in diagnostic processes.
  • The application explicitly does not replace psychotherapy.
  • Intended users:

    Patients before, during, or after treatment of mental disorders

    • Age >18
    • All genders
    • General ability to use a smartphone and a web-application (reading, listening)
    • Internet Access
    • Access to a smartphone and a 3rd party Appstore (Apple Appstore, Google Play)
    • no, minimal, mild, and moderate mental disorders
    The app may not be suitable for individuals with severe mental disorders including organic mental disorders (F0), most substance-related disorders (F1x.0, F1x.2, F1x.3, F1x.4, F1x.5, F1x.6., F1x.7), schizophrenia, schizotypal and delusional disorders (F2), severe depressive episodes (F32.2, F32.3, F33.2, F33.3), bipolar affective disorders (F30, F31, F34.0), dissociative disorders (F44, F48.1), intellectual disabilities and neurodevelopmental disorders (F7, F8).
    We declare that the MindDoc monitoring and self-management application meets the provisions of Annex VII of the Council Directive 93/42/EEC for medical devices. Our EU declaration of conformity is issued under the sole responsibility of the manufacturer.

    Instruction for Use and contact

    Here you can read the current version of the MindDoc Instruction for Use in German and English. Our Support Team will assist you in receiving a printed version if required