GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE

Primary DI

04260592190015

Basic UDI-DI Code

06059219GMN00195

Reference

Brisa

Device Types

None provided

Regulation

Eu Mdr

Classification

Eu Md Class 2a

Status

On The Market

Manufacturer

Temedica GmbH

Brisa is a personal digital companion for people with MS to get informed about their disease, organize their life with MS and collect data in order to track their personal MS course and share the information with the treating physician(s). The product includes following clinical claim functions: - Medical Questionaires: The user wants a section where he or she can fill out various validated medical questionnaires like MFIS5- 5 questions, BDI-FS- 7 questions, PDQ-5 questions, BLCS (Bladder Control Scale)- 4 questions, BWCS (Bowel Control Scale)- 5 questions, SSS (Sexual Satisfaction Scale) - 4 questions and PDDS(Patient Determined Disease Steps)- 1 question. Entering this data helps him to get a better picture of his personal disease development and he can provide his doctor with better information. - Symptom Tracking At regular intervals, the user is interviewed about relevant user-reported data from the field of MS, such as Fatigue, Depression, Cognition, Bladder Dysfunction, Bowel Disorder, Sexual Dysfunction and Disability. These data help the user to follow his own disease progression and provide better information to his doctor. - Data Sharing with HCPs: In order to inform his attending HCP about the course of the disease, the user should be able to share the disease data he has entered with his HCP. For this purpose, there should be a function that allows the health data to be made available to the doctor in a simple manner. There will be various export functions such as email, PDF for printing or a special dashboard where the doctor can view the user's data. The Produkt includes additional non-clinical functions: Personalization & Customization, Motivation & Gamification, Reports & Data Graphs, Situated Data and OcreButler/Therapy Preparation.

Other on-the-market devices with the same classification (Eu Md Class 2a) and regulation (EU MDR).