Notified Bodies Apply For EU MDR/IVDR Designations Despite Document Shortfall
If there is a delay in appointing EU notified bodies under the new Medical Device and IVD Regulations, it will impact the whole sector's ability to comply in time. But nothing is quite ready.
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New codes that indicate the scope of notified bodies under the new EU regulations are nearly ready. Will the first implementing act be out on November 26?
A crucial document for industry, the roadmap to the implementation of the EU's new medtech rules, finally seems on the cusp of readiness – four months after the rules entered into force.
Three new draft documents relating to notified bodies list the codes being prepared to determine their scope of responsibility for designation under the new EU medtech regulations and the raft of documentation they will be asked to submit when they apply for redesignation.