Industry Voices Growing Frustration Over Notified Body Designations Despite Latest Listing
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.
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The latest update in the Medical Device Regulation page of the European Commission's Nando database represents the 18th listing under the new regulation. Numbers are rising slowly.
Stakeholders have access to the first version of the European Medical Device Nomenclature, an aid to identifying the precise type of device being referred to. And their views on the naming system are being sought too.
The EU MDR date of application is three weeks away; while this date may look more tenable than before, deadlines in 2022 and 2024 leave the medtech industry, and especially its IVD sector, wondering how to stop products being lost from the market.