Submission stop for trials with medical device

The European Medical Device Regulation (MDR) comes into effect per 26 May 2021. As a consequence the rules for submission, review en performance of clinical trials with medical devices change. Trials with a medical device that have been approved by the METc UMCG before 26 May 2021 may continue according to current rules and regulation, […]

MDR postponed for one year

The European Union has decided that the implementation of the Medical Device Regulation EU 2017/745 (MDR) will be postponed for one year due to the Corona pandemic. The European regulations for medical devices and in vitro diagnostics will apply in 2021 and 2022 respectively. More information about the consequences of the medical device regulation on clinical investigations is available […]