EUMDR2017:745

MDCG publishes MDR Surveillance Guidelines

MDCG publishes MDR Surveillance Guidelines

MDCG publishes MDR surveillance guidelines regarding the transitional provisions under Article 120 of the MDR with regard to devices covered by certificates according to the MDD or the AIMDD.

EU MDR 2017/745 What Changed?

EU MDR 2017/745 What Changed in regard to the Medical Device Directive and how to implement them in your current quality management system?

The new medical device regulation, EU MDR 745/2017, has several additional criteria in regard to previous legislation. This new regulation also has a stronger connection to EN ISO 13485:2016. What modifications have been made to the prior medical device regulation, and how must you implement these changes in your current quality management system?