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.
Final adoption of EU rules making it mandatory to register in the Eudamed medical device database as of late 2025 now looks like a formality.
The commission expects to reach its conclusions before the end of 2025. This will signal what regulatory changes the EU medtech sector can expect thereafter.