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, […]
CCMO will be the competent authority for clinical investigations with medical devices
Starting 1 October 2020, CCMO will be the competent authority for clinical investigations with medical devices. This means that from then on, CCMO will take over the tasks of the Health and Youth Care Inspectorate (IGJ) for processing the notification of these investigations. See the original item on the website of the CCMO: link
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 […]