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

 

 

Intended Use

The MindDoc monitoring and self-management application medical device provides continuous long-term symptom monitoring for individuals with mental health problems. This enables users to recognize patterns in their symptom trajectories which then can be shared with a mental health care provider or used for self-management. MindDoc thus

  1. provides users orientation regarding the need to consult a mental health care provider who can use the monitoring data to prepare an actual diagnosis and support a follow-up therapy.

  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.

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), bipolar affective disorders (F30, F31, F34.0), dissociative disorders (F44, F48.1), mental retardation (F7), and disorders of psychological development (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.