The Medical Device Regulation 2017/745 (MDR) states that clinical investigations must be performed according to good clinical practice (ISO 14155:2020 Clinical investigation of medical devices for human subjects – Good clinical practice). In addition to complying with the requirements set in the MDR itself, sponsors must also be aware of the requirements set in the ISO standard.
We have created a guide on what you need to know about the good clinical practice requirements regarding the clinical investigation set-up, monitoring and ending phase. In the guide, we have highlighted the issues that, according to our experience, can sometimes be a bit unclear from the perspective of sponsors.
