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.
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Some 20 notified bodies were due to apply for designation under the EU's new Medical Device and IVD Regulations on November 26, and more after. The European Commission published needed codes for the process just one day before the application process began. Could that have created a hold up?
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.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Thirteen new guidance documents were posted to the tracker in August.