In general, ICH E6(R2) and ISO 14155 are similar; there are slight differences which are, in my opinion, only on a formal/minor level. From my point of view the ISO 14155 is more technical and in some parts more detailed than GCP. >> If a clinical trial on a medical device in GERMANY is conducted according the the German Medical Device Law, then investigator's need to provide a training certificate on ISO 14155 and relevant German legislation on medical devices. Therefore, ISO 14155 trainings exist in Germany. Many of them are designed as addon-trainings to GCP trainings. In other words: Investigators need to have GCP trainings as it is required for trials with medicinal products and in addition they need to have an ISO 14155 training. I guess this will not help you that much, but I can only share my experiences from medical device studies in Germany. >> I am unsure whether the EU Medical Device Regulation has some specific requirements included?