MDR & FDA Statement


    Our app imitoWound is a class I medical device according to Article 1 of EU Directive 93/42/EEC – MDD.

    imitoWound is a software application used in supporting the treatment of an individual patient in the wound and stoma healing process. Patient Metadata, wound image data and wound documentation information is brought into imitoWound by healthcare professionals by hand and connected information systems. The usage duration of the app is transient, however, the documentation of wounds as well as treatment and reaction time is a long-term process. The patient is documented and tracked in follow-up examinations over several weeks and months. imitoWound offers an image-centered wound timeline that enables healthcare professionals to monitor the healing progress and provides objective and precise wound measurement information by using imito’s clinically validated digital planimetry method. imitoWound actively informs about stalled healing processes and facilitates collaboration of health care professionals on individual wound cases. Therefore, imitoWound speeds up the diagnosis process and enhances the wound experts diagnosis accuracy. It therefore enables a better-timed treatment of wounds and reduces the risk of further developing chronic wounds (i.e. pressure ulcers, ulcus cruris, diabetic foot). Diagnosis and treatment decisions are the sole responsibility of the wound expert. imitoWound only serves as a diagnosis support tool and does not provide diagnoses itself.

    Cutimed Wound Navigator

    The app is not regulated by the European Union MDR because its intended use is not a medical one. It is intended for documentation (storage & archiving / filing), communication, simple search and data representation/improvement and is limited to providing information about BSN Products comparable to a catalogue which is subject to interpretation by a health care professional.

    Other imito Apps: imitoCam, imitoScan, imitoMeasure

    Our other apps and programs are not regulated by the European Union MDR. These smartphone applications, web-based solutions and server-side components are intended for medical and medico-administrative documentation (storage & archival), communication, simple search and data representation/embellishment.

    According to the European Union Medical Device Regulation (MDR) “Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR” and based on following intended purposes listed below.

    According to the United States FDA “Guidance on Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices, September 2019” and pursuant section 520(o)(1)(D) of the FD&C Act, software functions that are solely intended to transfer, store, convert formats, and display medical device data or medical imaging data are not devices and are not subject to FDA laws and regulations applicable to devices. imito programs and their intended purposes listed below are within this definition (“Non-Device-MDDS”) and therefore not enforced by FDA to comply with the regulatory controls.

    • Documentation of clinical pictures & movies, wounds (digital photo documentation).
    • Area measurement.
    • Storage, transfer and archival of data to the EHR (integration to EHR).
    • A communication system for Healthcare Professionals (commenting & mentioning).
    • Communication for DICOM modalities (Easy DICOM worklist).
    • Simple search support (Picture: manual tagging & search).
    • Scanning and archiving of medico-administrative reports and documents.
    • Documentation of wounds, dermatological lesions, specimen, etc. (digital photo documentation).