The sponsor – must be established in the Union itself or through a legal representative – and a qualified investigator are responsible for the supervision of the clinical investigation. The sponsor also determines the appropriate monitoring and conduct of the clinical trial. Articles 62-80 of the MDR set out the requirements for clinical investigation. DIN EN ISO 14155: 2021 sets out the procedure in even more detail, to which manufacturers of medical devices must devote their attention.
Clinical investigation are carried out in successive phases: from the definition of objectives, through trial planning and preparation, to the final evaluation and assessment of the data obtained.
All data recorded and collected during the investigation must be stored by the sponsor or investigator in accordance with the applicable data protection regulations. Suitable technical and organisational measures should be taken in advance. In the event of emergencies involving the participating groups of people after the trial, the sponsor must define a plan for the immediate recall of the medical devices.