EU Regulatory Reads, February 2018: Brexit And Notified Body Muddle; HTA And Reprocessing
Executive Summary
Much speculation and little certainty means notified bodies and Brexit continue to dominate headlines as one UK notified body is phased out. News and insights on single-use device reprocessing and health technology assessments also attracted attention last month.
You may also be interested in...
EU Regulatory Experts Support Notified Bodies, But Argue For Greater Consistency
Notified bodies have been a pivotal part of the EU medtech regulatory system since it was first launched in the 1990s. Where might they fit within a new medtech regulatory governance structure? Panelists on a recent vodcast grappled with the question.
First Public Discussion On How EU Medtech Regulatory Governance Structure May Evolve
Does the EU need a medtech agency for the first time in its history? Nothing can or should be decided too quickly but five high-profile experts broadly agreed that change is now critical.
First Danish Notified Body Named Under EU's Medical Device Regulation
The EU now has a total of 45 notified bodies under the MDR.