Notified Bodies And EU Industry Voice Separate, But Aligned Frustrations Over Slow Progress In NB Designations
Notified Bodies And EU Industry Voice Separate, But Aligned Frustrations Over Slow Progress In NB Designations
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EU notified bodies associations are sounding the alarm that delays in designation could result in a host of problems in making medical devices available. They warn that designation delays represent the largest hurdle in keeping products on the market after the Medicines Device Regulation (MDR)’s May 2020 deadline.
Publisher: MedTech
- Description
Difficulty in obtaining notified bodies designation is being identified as the main reason some medical devices may miss the Medicines Device Regulation (MDR)’s May 2020 deadline for certification, say several EU medical device manufacturing associations. Dig deeper into the concerns of medical device trade associations in this informative article from Medtech Insight, which explores concerns about notified bodies designations from industry associations, who warn that such delays could result in product shortages, and more.
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