An investigation into the impact of the MDR Clinical Data Requirement for Legacy Devices & Transitional Provisions set out in Regulation EU 2023/607 on Medical Device manufacturers.

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Duggan , Manus
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OBJECTIVE: This study investigated the impact of the Medical Device Regulation requirement of clinical evidence for legacy devices and the transitional timelines on medical device manufacturers in Ireland. The MDR legislation which came in force on 26th May 2021, sets out the legal regulatory framework for medical device manufacturers, who wish to place their product on the EU market. Four key objectives were identified; firstly, to establish the current status regarding obtaining CE mark certification for medical devices. Secondly, to determine the status of products needing re-certification under MDR. Thirdly, to determine if the manufacturer in their opinion considers the transitional provisions set out under Regulation (EU) 2023/607 is sufficient. And finally, to obtain recommendations from industry as to improvements needed to improve the process of MDR certification. METHODS: Secondary research was conducted of peer-reviewed journals, books, newspaper articles, and organisational websites, using the terms MDR, clinical data, medical device, and legacy medical devices. Primary research was conducted by means of a survey questionnaire, which was answered by 27 people with significant knowledge of medical devices in Ireland. One of the survey respondents worked in academia. Interviews took place with two individuals one from academia, and the other with a regulatory background in a medical device company. RESULTS: In this study it was found that the introduction of the MDR legislation has had a negative impact on the medical device industry. Start-up and SMEs have been severely impacted by the requirements of the MDR, particularly the financial cost of clinical trials and access to Notified Bodies for MDR assessment. The clinical evidence requirement is ambiguous and impacts even the larger companies. Access to Notified Bodies, and the time taken by Notified Bodies to assess devices is taking much longer than under previous legislation. There have been device shortages and withdrawals warning from industry sources, but the consequence of this is unclear, and close monitoring of the situation is needed. Orphan and paediatric device shortages have already happened in the EU. CONCLUSIONS: In this study, the author found that the primary research data broadly corresponded with what was found in the secondary research data. Clinical evidence is causing the most issues for companies. The EU have not been pro-active in their response to issues encountered by the medical device industry. The primary research sample size was limited, and warrants further study with a larger sample size

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