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.
Book Free Consultation →Request a QuoteAny manufacturer outside the EU selling medical devices in Europe. Required from Day 1 — no grace period for non-EU companies entering the EU market for the first time. Also needed by EU manufacturers preparing for EUDAMED mandatory registration (28 May 2026).
EU AR appointment: 5 business days onboarding.
EUDAMED registration: 1–3 weeks (depends on device count).
Gap analysis: 2–4 weeks.
Full MDR technical file: 8–16 weeks depending on device class and existing documentation.
EU AR (annual): fixed fee, varies by device class.
Gap analysis: fixed project fee, delivered in 2 weeks.
Technical documentation: fixed fee per device, scoped before engagement.
No hourly billing. No surprise invoices. Request a fixed-fee quote →