Worldwide data derived from clinical investigations are often expected to obtain market approvals of medical devices and are critical to verify the performance and safety in the post market phase. The results of the clinical investigation are also a key input to clinical evaluation demonstrating compliance with regulatory requirements. 

Preclinical data and results from an ongoing risk management are an important input for the planning and rationalizing of a clinical investigation. Ethical and business perspectives need to be considered very carefully for the determination of appropriate objectives. Therefore, compliant, and methodological sound planning, conduct, documentation, and reporting of clinical investigations of medical devices for human subjects are required to obtain reliable and ascertain valid clinical data during different steps in the life cycle of medical devices.

National regulatory framework and the international Standard ISO 14155:2020 “Clinical investigation of medical devices for human subjects – Good clinical practice” ensure a high level of patient focus and in best case international accepted results. Many national authorities or frameworks recommend, refer, or even expect the application of the ISO 14155. During this training the history, content, applicability of ISO 14155 and interrelation to MDR and relevant MDCG documents will be main topics.