NordMDR AB is a Stockholm-based EU MDR consultant providing Authorized Representative services, CE marking, technical documentation and EUDAMED registration for medical device manufacturers from anywhere outside the EU. Fixed fees. 5-day onboarding. All 27 EU member states.
NordMDR AB is a Stockholm-based EU MDR consultant providing full regulatory compliance support for medical device manufacturers from anywhere outside the EU. We handle every step from initial gap analysis to CE marking and ongoing post-market obligations.
Mandatory legal appointment under EU MDR Article 11. We act as your EU legal address, handle EUDAMED registration and all Competent Authority communications.
Audit of your existing documentation against EU MDR requirements with a clear compliance roadmap, timeline and fixed cost estimate.
Complete Technical Files under Annex II and III — risk management, clinical evaluation, post-market surveillance plans for all device classes.
Full actor and device registration — mandatory from 28 May 2026. SRN acquisition, device registration, UDI entries and annual maintenance.
End-to-end CE marking for medical devices, electronics and machinery including EMC compliance under EU Directive 2014/30/EU.
ISO 26262 automotive functional safety, IEC 61508 industrial safety, FMEA and hazard analysis for safety-critical systems.
Free 20-minute compliance assessment — honest guidance on exactly what your product needs. No obligation.
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