Abstract
The European Union Medical Device Regulations 2017/745 entered into force on May 2021 with changes related to strengthening the clinical evaluation requirements, particularly for high-risk devices. This study investigates how the increased requirements on medical device manufacturers in relation to how clinical evaluation will challenge manufacturers. A quantitative survey study was utilized with responses from 68 senior or functional area subject matter experts working in medical device manufacturing Regulatory or Quality roles. The findings from the study demonstrated that the highest source of reactive Post-Market Surveillance data was customer complaints and proactive data were Post-Market Clinical Follow-Up. In contrast, the top 3 sources for generating clinical evaluation data for legacy devices under the new Medical Device Regulations were Post-Market Surveillance data, Scientific literature reviews, and Post-Market Clinical Follow-Up studies. Manufacturers' biggest challenge under the new Medical Device Regulations is determining the amount of data needed to generate sufficient clinical evidence, while over 60% of high-risk device manufacturers have outsourced the writing of their clinical evaluation reports. Manufacturers also reported a high investment in clinical evaluation training and highlighted inconsistencies in the requirements for clinical data by different notified bodies. These challenges may lead to a potential shortage of certain medical devices in the E.U. and a delay in access to new devices, negatively impacting patient quality of life (1). This study provides a unique insight into the challenges currently experienced by medical device manufacturers as they transition to the MDR clinical evaluation requirements and the subsequent impact on the continued availability of medical devices in the E.U.