The notified-body bottleneck
~45–50 notified bodies for the whole EU, 13–18 month timelines — and 75% of submissions need significant remediation first.
Free field guide · PDF
EU MDR Medical Device Certification2026 Field Guide
Notified-body capacity, the Article 120 transition deadlines, and the real budget for CE marking under the MDR.
- NB timeline
- 13–18 mo
- Class III deadline
- Dec 2027
- Typical CE budget
- €50K–300K
Sourced from MDR transition guidance and notified-body fee schedules.
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What's inside
Five pages, zero fluff
Every figure in this guide traces to a named source — MDR transition guidance and notified-body fee schedules.
The Article 120 clock
Article 120 deadlines under Regulation (EU) 2024/1860: Dec 2027 for Class III, Dec 2028 for Class II.
The real CE-marking budget
Typical total budgets of €50K–€300K by class — notified-body fees, technical documentation, and the mandatory EU Authorized Representative.
Sources & scope
- MedDeviceGuide, EU notified-body selection under the MDR: 2026 guide.
- Patient Guard, EU MDR Article 120 transition deadlines explained.
- RegDesk, major differences between MDR/IVDR and MDD/IVDD.
- ElendiLabs, French market entry costs under the EU MDR.
This guide is market-access intelligence, not regulatory or legal advice. MDR requirements and notified-body timelines are device-specific — professional review is required before business use.
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