Based on BlueAsia’s real project cases since 2025 Aug 1 enforcement, we sort practical certification steps and actual turnaround duration.
Step1: Compliance scope confirmation within 1 working day:
Confirm MDR/IVDR medical exemption, applicable 3.3(d/e/f) clauses and final compliance path (DoC or NB) against (EU)2025/138 restrictions.
Step2: Security document preparation, the most time-consuming segment:
Core files include TARA threat assessment report, EN18031 clause mapping document, firmware version record and encryption scheme description, compiled by R&D team or supported by professional certification agency.
Step3: Lab verification covering document audit, firmware vulnerability scanning and practical security function validation:
Simple Bluetooth goods take 3–5 working days; multi-network IoT devices need 5–8 working days or longer.
Step4: Final certification approval:
·DoC route: Total cycle 1.5–2.5 months for ready-made product security design; 3–5 months for products requiring supplementary security development.
·NB route: Extra NB queue & document review period, medium-sized EU NB takes 10–15 working days for document review while top brands TÜV/SGS need 3–6 weeks; overall project starts from 4 months plus possible modification delay.
NB certification certificate stays valid permanently as long as core hardware, firmware security framework remain unchanged without major revision.
BlueAsia helps customers optimize process to shorten certification period. Contact:13534225140
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