University of Twente Student Theses


Implementation of clinical evaluation within an existing overall development framework

Geel, Emma van (2019) Implementation of clinical evaluation within an existing overall development framework.

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Abstract:In April 2017 the new regulation for medical devices (MDR) was introduced. This new regulation replaces the Medical Devices Directive (MDD) and Active Implantable Medical Devices Directive (AIMDD). The new MDR will become effective in April 2020. This means that the market access framework for all member countries of the European single market 1 will change significantly. But also for products already on the market, as these will need to be reclassified according to the MDR classifications. Timeframe for this is unknown as the notified bodies are not accredited yet. Demcon is an Enschede based company which develops and produces medical devices, some of which they market themselves. To prepare them for the new MDR, focus groups were held with the key stakeholders at Demcon in the field of; quality assurance, regulatory affairs and clinical research performance, with a focus of developing a framework with which they could comply to one of the major changes in the MDR; performing clinical evaluations for the product. After distilling the MDR requirements for clinical evaluation and investigation these could be mapped on the stage gate model. A framework used by Demcon for the development of their products. During discussions with the stakeholders this resulted in the development of a new procedure for clinical evaluation and corresponding registration forms to help guide the process. The new procedure was intended to be tried out on two developmental projects. However when the procedure was finished it was found that only one of the projects was at a stage where the clinical evaluation could be set-up. It was found that the new procedure adequately matched the stages of the Demcon overall development process. The product under evaluation was granted the CE mark by the notified body after evaluating the clinical evaluation. The primary conclusion is that the developed framework (the procedure and the registration foms) match the requirements of the MDR with only small improvements found in this first test. However, two uncertainties about the implementation of the MDR remain; firstly the exact interpretation of the MDR is not known, a lot of articles in the MDR are still up for discussion between EU member states and the notified bodies. And second, it is not until April 2020 that the MDR will be enforced for the new and already existing medical devices. Therefore it cannot be stated at this point in time if the framework will be sufficient for the actual standards notified bodies will maintain when evaluating the clinical evaluations. More information is to be gathered from Regulatory professionals on what to expect from the actual implementation of the MDR. The developed framework serves as a good starting point and can be adapted to any additional requirements coming forth from regulatory experts on the MDR.
Item Type:Essay (Master)
DEMCON, Enschede, NL
Faculty:TNW: Science and Technology
Subject:01 general works
Programme:Health Sciences MSc (66851)
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