MDCG Q&A on MDR vigilance terms and concepts

The Medical Devices Coordination Group (MDCG) has issued new guidance clarifying important terms and concepts on vigilance stated in the Medical Devices Regulation (MDR) 2017/745. Among others, this guidance, following a Q&A format, addresses the following topics:

Difference between an ‘incident’ and a ‘serious incident’ with a device under the MDR

The main difference between an "incident" and a "serious incident" under the MDR is the severity of the related health or . . .


Oh! It looks like you do not have access to this page.
Find the membership plan that suits you, and within a few minutes you are good to go.
Are you a member already? Log in here.