Notified Bodies And EU Industry Voice Separate, But Aligned Frustrations Over Slow Progress In NB Designations
Notified body and medtech industry trade associations both issued formal statements pointing out that delays in designating notified bodies are the biggest barrier to products being able to comply with the new EU Medical Device Regulation before deadlines. Time is running out.
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One In Three Medtech Innovators Will Be 'Driven Out Of Business' By EU MDR, German Business Survey Finds
The EU Medical Device Regulation is 15 months away from being implemented in full, and a new German survey about its potential impact on the medtech innovation and patient-care landscape makes for sobering reading.
The last year of the run up to the full implementation of the MDR has been characterized by a flurry of new documents and measures, but industry is adamant that medtech is heading for a crisis that will impact industry and patients alike.
With just a few months remaining until the full application of the EU Medical Device Regulation, notified body designations are still only trickling through. Ireland is the latest EU member state to have a resident MDR notified body.