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Notified Body Training Session Highlights Need For More Support For SMEs

 
• By Amanda Maxwell

The EU notified body association, TEAM-NB, is working hard to support industry with its MDR and IVDR compliance efforts. Its first technical documentation training session highlighted where help is likely to be most needed.

Desperate office worker overwhelmed with paperwork, she is asking help with her hand
Notified Bodies Offer Training To Help Medtech Manufacturers Meet Challenging MDR And IVDR Requirements • Source: Shutterstock

Small and medium-sized enterprises (SMEs) accounted for 73% of medtech manufacturers attending a recent training on how to prepare technical documentation to meet notified body expectations in the context of the EU’s Medical Device and IVD Regulations (MDR and IVDR). That is according to the EU notified body trade association, TEAM-NB.

A total of 19% of the 50 organizations that attended were large manufacturers, and the remaining 8% were consultants. 

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