EU and Switzerland

imito’s apps and programs are not regulated by the European Union MDR. These smartphone applications, web-based solutions, server-side components, and mobile SDK 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 the following intended purposes listed below.

US

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.

Australia

According to the guidance issued by the Australian Therapeutic Goods Administration (Department of Health), “Examples of regulated and unregulated software (excluded) software based medical devices”, Electronic Patient Records (EMRs) and Electronic Health Records (EHRs), i.e. software used to electronically receive, collect, store, manage, display, output, and distribute data within or between healthcare facilities, to support the electronic registration and documentation of patient clinical data, are not medical devices and are not subject to any TGA regulatory requirements. imito programs function as part of EMRs / EHRs and provide the same functionality and thus are not enforced by TGA to comply with the regulatory controls.

South Africa

According to the “Guideline on Questions and Answers: Licensing of Medical Device Establishments” issued by SAHPRA, a medical device is any instrument, appliance, material, machine, apparatus, implant or diagnostic reagent- (a) used or purporting to be suitable for use or manufactured or sold for use in- (i) the diagnosis, treatment, mitigation, modification, monitoring or prevention of disease, abnormal physical or mental states or the symptoms thereof; or (ii) restoring, correcting or modifying any somatic or psychic or organic function; or (iii) the diagnosis or prevention of pregnancy, and which does not achieve its purpose through chemical, pharmacological, immunological or metabolic means in or on the human body but which may be assisted in its function by such means; or (b) declared by the Minister by notice in the Gazette to be a medical device, and includes any part or an accessory of a medical device. imito programs are designed solely for the purpose of storing, transferring, converting formats, and displaying medical device data or medical imaging data and thus are not enforced by SAHPRA to comply with the regulatory controls.

imitoCam

• Documentation of clinical pictures & movies, wounds (digital photo documentation).
• Area measurement.
• Storage, transfer and archival of data to the EMR (integration to EMR).
• A communication system for Healthcare Professionals (commenting & mentioning).
• Communication for DICOM modalities (Easy DICOM worklist).
• Simple search support (Picture: manual tagging & search).

imitoScan

• Scanning and archiving of medico-administrative reports and documents.

imitoMeasure

• Documentation of wounds, dermatological lesions, specimens, etc. (digital photo documentation).

imitoWound 3.0

• Documentation of wounds & stoma (digital wound documentation).
• Wound area measurement.
• Storage, transfer and archival of data to the EMR (integration to EMR).
• Simple search support

WoundGenius 1.0 (Mobile SDK)

• Image capture of wounds, dermatological lesions, specimens, etc.
• Area Measurement.
• Transfer of data (image, metadata) to the mobile app

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.