EU standards web portal offers new opportunities to device SMEs
This article was originally published in Clinica
Executive Summary
The European standards organisations, CEN and CENELEC, have launched a new web portal to help small and medium-sized enterprises work with standards. This will be of particular interest to the European medical device community – SMEs account for 80% of the European medtech industry.
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.