Notified Bodies Apply For EU MDR/IVDR Designations Despite Document Shortfall
Executive Summary
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.
You may also be interested in...
Notified Body Codes: EU Commission Needs To Act Fast
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?
EU Roadmap: Finalized Plan For Implementing New Regs Coming Next Month?
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.
Over 170 Provisional Draft Codes Published For Notified Body Designation Under MDR & IVDR
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.