The Impact of Medical Devices Regulations on Notified Bodies and Additive Manufacturing

Sammanfattning: The medical device regulatory system, as well as the medical device market in the European Union (EU), is now facing challenges posed by the newest regulation, Medical device regulations (MDR). Researches have shown concerns and possible consequences related to this new regulation system from both the regulatory approval procedure and market development perspectives. This study aims to elaborate on a practical and objective situation of this latest shift and picture out a predictable scenario for the implementation of future technology like Additive Manufacturing (AM) in healthcare. These two objectives are addressed from the perspective of the core role in this system, Notified Bodies (NBs). Specifically, it answers the following questions: What is the impact of the MDR on the NBs’ operations? What is the impact of the MDR on the device building on AM from NBs’ perspective? A literature review is conducted on existing researches in the relevant fields mentioned in the research questions of this study. Then a self-completion questionnaire is generated and sent to NBs who offer the CE marking granting service for the medical devices around the EU. The eight responses for the survey indicate that the MDR influences NBs and the device building on AM from several perspectives. For the NBs, the number of NBs will decrease while the workload and new recruitment will increase. Also, the independence and competences of NBs will be improved by MDR. In the case of AM-relevant medical devices, MDR will pose specific issues on them while the market will be developed by ensuring the product quality and raising public awareness. These findings are valuable practical evidence to examine the application of MDR and the implementation of technology like AM in healthcare under MDR. Overall, it found that the MDR will cause a tough situation in the short term. At the same time, the far-reaching influence for the regulatory system, as well as the medical device market, is affirmative and expectable worthy.