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Medical Device Obligations Taskforce

Periodic Reporting for period 1 - MDOT (Medical Device Obligations Taskforce)

Reporting period: 2019-01-01 to 2020-06-30

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, also places a heavy burden on medical device innovation in Europe, since the clinical and reporting/surveillance requirements will greatly increase. 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), an exchange network enabling automated conformity assessment proceedings and the transfer of technical and clinical performance data across Europe. In a 5-year project (2019-2023) the platform is developed including 3 demonstrator technologies in the fields of inhalers, neural implants, and coatings for hip replacements. Through the MDOT platform manufacturers can be informed about the requirements that have to be fulfilled for their conformity assessment, compile the required documentation, “buy-in” to existing data and safely share their own results, and receive access to advanced and upgraded testing methods when additional data is required.
The overall aim of MDOT is the prevention of a massive loss of innovation and economic strength in the European medical device industry by provision of expertise and data by a consortium of medical device stakeholders.
In the first 18 months of the project the MDOT network focused on the following aspects to enable SMEs to fulfil the conformity assessment requirements:
- Data structures were developed compatible with the regulatory requirements, mostly focusing on biocompatibility and clinical evaluation aspects covering the fields of inhalers, neural implants, intraocular lenses, and coatings for hip replacements
- Different database systems were assessed towards feasibility in terms of providing data structures developed
- Materials libraries including characterization and testing have been developed for different material combinations useful for medical devices
- Testing infrastructure is continuously improved towards provision of access to advanced safety testing of modern medical device technologies
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.
Concept of simplifying the conformity assessment within the platform developed in MDOT