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Medical Devices / Regulatory Affairs

EU Releases Long-Awaited Designation Codes for Notified Bodies

Dec. 8, 2017

The European Union Notified Bodies Operations Group released long-awaited codes for medical devices and in vitro diagnostics that correspond with the new EU regulations.

Conformity assessment bodies will need to use the new codes when submitting applications to become notified bodies (NBs). The codes define the scope of medical products that are covered, including medical devices and IVDs, so that manufacturers can determine which notified bodies to contact for conformity assessments.

It has been critical to get the list published quickly as the application process to become a NB went live on November 27.

“These codes have been long-awaited, as they form the basis of the notified body designation under the new EU MDR and EU IVDR,” Gert Bos, executive director at medical device regulatory consulting firm QServe Group, told FDAnews.

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