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Industry Voices Growing Frustration Over Notified Body Designations Despite Latest Listing

 
• By Amanda Maxwell

One more name has appeared in the European Commission list of notified bodies designated under the MDR and marks the the first time a Croatian company has been appointed. This time, the fanfare has been overshadowed by frustration from the industry as EU medtech regulation deadlines approach.

Croatia flag

The 18th notified body to be designated under the EU Medical Device Regulation is UDEM Adriatic – the first Croatian notified body to be officially listed against the MDR.

The organization has been designated for a broad range of active non-implantable and non-active devices, as well as for...

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