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Over 170 Provisional Draft Codes Published For Notified Body Designation Under MDR & IVDR

 
• By Neena Brizmohun

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.

The European Commission’s Notified Body Operations Group has published two draft lists comprising 171 codes that might be used to determine a notified body’s scope of designation under the new EU medical device and IVD regulations. NBOG has also released a third document – a draft list that signals the breadth of documentation notified bodies might be asked to provide when it comes to applying for redesignation under the new regulations.

The lists, which were published in August, have not yet been adopted or endorsed by the commission and must not...

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