Periodic Reporting for period 2 - MDOT (Medical Device Obligations Taskforce)
Período documentado: 2020-07-01 hasta 2021-12-31
To support SMEs and simultaneously enhance quality, regulatory compliance and patient safety, we establish the Medical Device Obligations Taskforce (MDOT), a network enabling conformity assessment proceedings and the transfer of technical and clinical performance data across Europe. In a 5-year project (2019-2023) a platform is developed including three demonstrator technologies in the fields of inhalers, neural implants, and orthopedic coatings. Through the MDOT platform manufacturers can be informed about the requirements that have to be fulfilled for their conformity assessment, compile the required documentation, receive access to advanced and upgraded testing methods and data.
The overall aim of MDOT is a push of innovation and economic strength in the European medical device industry by provision of expertise, test bed development and data by a consortium of medical device stakeholders.
- Test beds were further developed to the stage of operation in relevant environments
- Databases were generated for data structures previously developed, to include data on norms and standards, testing, materials and devices
- Models for sustaining the MDOT platform and network beyond project phase were assessed and investigated