New Regs Lead EU Notified Body Association To Suspend Code-Of-Conduct Audits
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?
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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.
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.
What will the fall-out of political tensions between the EU and Switzerland mean for notified bodies based in Switzerland, and for the future recognition of CE marks granted in one of the most important medtech markets in Europe?