As of 26 May 2021, Regulation (EU) 2017/745 also known as the Medical Device Regulation (MDR) became applicable in the European Union, replacing the previous Directives for Medical Devices (93/42/EEC and 90/385/EEC). The new law significantly changed the European legal framework for medical devices, introducing new principles and responsibilities for the national authorities. As of the implementation of MDR, sponsors are required to submit notifications through the national Competent Authority in EU/EEA concerning clinical investigations of already CE-marked medical devices that are to be used within their intended purpose. The aim of this study was to investigate and assess the study documentations submitted with a notification of a clinical investigation concerning a medical device, and their alignment with what is required according to MDR and applicable national legislation and guidance. The method involved systematic verification of essential documents, including evidence of CE-marking and alignment with intended purposes. Systematic controls ensured consistency, and data analysis identified patterns and implications for regulatory adherence. The data analysis included all 42 notifications submitted to the Swedish Medical Products Agency within the timeframe 26/MAY/2021-31/MAY/2023. The results revealed a consistent submission of some essential documents, which demonstrated a foundational understanding of regulatory requirements, but also some notifications that lacked alignment with the MDR and applicable standards, suggesting a knowledge gap among sponsors and emphasising the need for enhanced awareness and compliance.