New Regs Lead EU Notified Body Association To Suspend Code-Of-Conduct Audits
Executive Summary
TEAM-NB needs to redirect resources from notified body oversight toward helping its 22 members fall into line with requirements under the forthcoming Medical Devices Regulation and IVD Regulation. So what does this mean for TEAM-NB non-members and future notified body numbers?
You may also be interested in...
What's Next For Notified Bodies: TEAM-NB President Discusses Challenges Ahead
A Q&A with Guy Buijzen, of TEAM-NB, on where things stand for notified bodies right now as the EU moves to adopt the new regulations for devices and diagnostics. The EU notified body association is redoubling efforts to prepare its members for the coming changes.
21 Notified Bodies Declare Intention To Stay In EU Game
Almost two dozen notified bodies say they will test against the new European Union Medical Devices Regulation, and 11 against the new IVD Regulation. Some certainty at last, but many questions remain.
EU Experts Want One-Stop-Shop EU Governance That Mimics Best Of Other Jurisdictions
It may be blue sky thinking to surmise how a new EU medtech regulatory governance structure could evolve. But with change on the horizon, experts see exciting opportunities.