The European Association for Medical devices of Notified Bodies (TEAM-NB) are asking the European Commission to think again about a proposed regulation that could lead to repetition in regulatory requirements… Read More
One of the main concerns when planning towards compliance with Regulation (EU) 2017/745 on medical devices (MDR) is the clinical evaluation. According to article 61 of the MDR, manufacturers must… Read More
The Medical Device Coordination Group (MDCG) has issued a new guidance document “to provide further detail on the operational and practical implementation of Articles 13 and 14 and other related… Read More
In earlier newsletter issues, we reported that additional EUDAMED modules were made available. In parallel, the European Commission expanded the website and associated subject areas with tabs for each module.… Read More
Although Regulations (EU) 2017/745 and 2017/746 on medical devices and in vitro diagnostic medical devices (MDR and IVDR) are in operation in the EU, medical devices legislation in Great Britain… Read More
