EU Regs: Resource Gaps Could Threaten Existing Products, But Some Protections In Place
Executive Summary
There is still a lack of clarity over whether notified bodies and competent authorities will find sufficient resources for the smooth implementation of the forthcoming Medical Devices and IVD Regulations. Does this mean some products considered safe today may have to be removed unnecessarily from the EU market?
You may also be interested in...
Staffing Challenges Dominate EU Medtech Regulatory Plans
EU Commission, competent authorities, notified bodies and industry: Everyone is struggling to find the staffing resources necessary to build the infrastructure for implementing the EU’s oncoming medtech regulations.
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.