Pilot study for MDR/CE mark
| Reference number | |
| Coordinator | Habbie HealthTech AB |
| Funding from Vinnova | SEK 195 549 |
| Project duration | February 2024 - May 2024 |
| Status | Ongoing |
| Venture | Medtech4Health: Competence Enhancement in SME |
| Call | Medtech4Health: Skills enhancement in small businesses 2023 |
Purpose and goal
The project´s aim is to map regulatory eligibility requirements for the implementation of AI in the Habbie service. We see that through this Habbie becomes a medical device, and that through this we need to classify Habbie according to the MDR and finally obtain a CE mark. The project aims to start this process, through a regulatory analysis and investigation of applicable requirements. The goal of the project is to start the process for compliance according to MDR and create knowledge within our organization about the eligibility requirements that are set for a CE marking.
Expected results and effects
Our vision includes implementing AI for motion analysis, which means that both patient and treating staff can gain insights based on users´ motion data. With this technology, the patient can receive feedback on his movements in real time to correct any errors in the execution. Treatment staff can - without having to study the patient in real time - get data and insights about the patient´s mobility and progress. At the end of the project, we should have strengthened our knowledge of MDR and started our process towards CE-marking.
Planned approach and implementation
In the project, we employ external consultants from Complyit with expertise in MDR and CE in particular. We work closely with the consultants to learn as much as possible about the regulations and our obligations as an organization, in order to be able to proceed with certification at a later stage. Work package 1: Regulatory analysis: Classification and plan of activities Work package 2: Applicable requirements