Periodic Reporting for period 4 - MDOT (Medical Device Obligations Taskforce)
Periodo di rendicontazione: 2023-07-01 al 2024-06-30
The Medical Device Regulation (MDR) introduces a new level of (i) patient safety, (ii) product reliability and (iii) enhanced clinical performance criteria within the conformity assessment process. This, however, together with the COVID-19 pandemic-related impacts, also places a heavy burden on medical device innovation in Europe. It is expected that SMEs are particularly affected by MDR’s extensive documentation and report obligations and new clinical testing requirements, which leads to a loss of innovation and consequently to a reduced number of medical devices accessible to European patients.
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.
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.
In the first 54 months of the project the MDOT network focused mainly on the development of data structures and data, materials libraries and improving and further developing testing infrastructure. Test beds were developed and/or finalized and partially applied, Decisions were made regarding the single entry point infrastructure.
The final 12 months were mostly spent on the following aspects:
- test bed application and analysis of the results
- preparation of prototypes for clinical testing
- preparation regarding regulatory affairs for conformity assessment of inhalation products
The final 12 months were mostly spent on the following aspects:
- test bed application and analysis of the results
- preparation of prototypes for clinical testing
- preparation regarding regulatory affairs for conformity assessment of inhalation products
A major goal in MDOT is to simplify the conformity assessment of medical devices by employment of automation where possible and sensible, accompanied by experts of the MDOT network where required. This will enable in particular MedTech SMEs and startups to understand the regulatory requirements of novel technologies to ensure safety in order to enter the market. Moreover, the network required for testing and/or test development can be provided. This has an impact on the European healthcare landscape since it can ensure access to state of the art medical devices. Most prominently, a device has been developed within the project that now undergoes clinical testing. If this is successful, we are planning for a start-up company to equip the health market with better solutions than current state of treatment.