A US-based non-invasive radio-surgical equipment manufacturer was looking to obtain the CE Mark for their Class IIb device and introduce it in the European market. The device approved by the FDA and marketed in the US. The client sought support with transitioning to the Medical Device Regulation (MDR) European Union (EU) Regulation 2017/745 regarding their Technical File and remediation of the Clinical Evaluation Report (CER). While the client already had all documentation in place per the Medical Device Directive (MDD), they had received observations from the Notified body (TUV SUD) on their previous submission.
The client aimed to address the observations and assess gaps in their current technical documentation to ensure that the device conforms to the requirements of the EU MDR. Another challenge that the client faced was the lack of adequate clinical data on the device, which was expected as the device was commercialised only in 2018.