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Place of High-risk Medical Devices in European Recommendations with a Focus on End-users
... Number of guidelines on clinical evaluation of medical device per member state(Brunotte 2020). ...
This position paper analyses the threats from the current situation of the clinical investigation to the expectations of the new European regulations focusing on high risk medical devices (HRMDs). We present also some opportunities to improve the feasibility and quality of clinical investigation. In summary, investigation protocols of medical devices, advised and authorized by the competent authorities, are few and heterogenous. There is a lack of quality in the existing studies, a lack of methodological knowledge and consequently high expectations for assistance from those involved in the design of clinical study protocols on HRMD. Guidance that is specific to the different type of devices is missing. Adaptive designs, pragmatic trial, usability methods, computer modeling and real world data are gaining more and more traction for assessing the safety and performance of high risk medical devices from a regulatory viewpoint .
... From the regulatory bodies' perspective, the European market is significantly fragmented because many countries have their own set of rules [23]. Even though the regulations are harmonized within the European Union, their implementation is left to the discretion of the member states. ...
A large proportion of the patient injuries or deaths attributable to medical device (MD) misuse can be eliminated and/or mitigated by adopting an effective human factors/ergonomics (HFE) approach. The implementation of a usability engineering process is now mandatory for MD manufacturers seeking to obtain the European Union's CE Mark. Here, we describe the European Union's HFE regulation and highlight the challenges faced by (i) manufacturers implementing this regulation and (ii) regulatory bodies charged with assessing the compliance of usability files. In Europe, 95% of MD manufacturers are small and medium-sized enterprises; compliance with the CE Mark regulations is a real challenge to their competitiveness. Levels of knowledge about HFE vary greatly from one regulatory organization to another, which can sometimes lead to very different expectations. We also present the specific use-related risk management approach required by the HFE regulation. Lastly, we focus on the limitations of the HFE regulation for MDs and on future HFE challenges in further reducing and/or eliminating MD use errors. The main challenge is the need to go beyond technology design and the pre-market assessment and to look at the post-production stage; the coupling between an MD and a sociotechnical system can led to consequences that were not predicted during the design process. This implies the need to consider the emerging properties of technologies in use by involving all the stakeholders.
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