NordMDR AB is a team of EU MDR consultants and MDR consultants based in Stockholm, 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.
Specialized regulatory cross-border consulting for US, UK, and APAC medical device manufacturers entering the European and Swiss markets.
Selling non-medical consumer goods? Learn about our GPSR Representative services for Amazon & EU e-commerce brands.
Searching for eu mdr consultants or mdr consultants? You need a partner who covers the full compliance chain — not just advice. NordMDR AB acts as your EU MDR consultant from first market-entry assessment through CE marking, Notified Body preparation, EUDAMED registration, and ongoing post-market obligations.
Our MDR consultants work directly with US, UK, and APAC manufacturers who lack an EU legal entity. We translate EU MDR 2017/745 requirements into actionable project plans with fixed fees — EU Authorized Representative appointment, EU MDR gap assessment, technical documentation under Annex II/III, and EUDAMED actor registration.
Classification, conformity route, clinical evaluation strategy, PRRC guidance, vigilance setup, and Competent Authority liaison — scoped before engagement.
Non-EU Class I–III manufacturers, legacy MDD certificate holders transitioning to MDR, and first-time EU market entrants without in-house regulatory teams.
Full EU legal entity, English-first delivery, Nordic pragmatism, and cross-border experience with Swiss CH-REP and UK MHRA pathways.
Consulting scopes your compliance project; your EU Authorized Representative is the mandatory legal appointment on your label. NordMDR provides both.
Led by a regulatory affairs specialist with two decades of hands-on experience across EU MDR, CE marking, EMC compliance, and functional safety — working directly with Notified Bodies and Competent Authorities. Read full bio.
NordMDR AB is a Stockholm-based EU MDR consultant providing full regulatory compliance support for medical device manufacturers from anywhere outside the EU — including the United States, United Kingdom, and Asia-Pacific. 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 QuoteFree 20-min call. Device class, markets (EU, UK, CH), existing certs, timeline.
Annex II/III review. Written report with gaps, severity, fixed-fee remediation plan.
Appoint EU Rep, actor SRN, device registration — bulk portfolios supported.
Remediation of documentation, clinical evaluation, PMS/PMCF for NB readiness.
CE marking support, vigilance setup, ongoing post-market obligations.
Typical engagement: US/UK manufacturer with FDA 510(k) → gap assessment → EU Rep → EUDAMED → Notified Body submission. US to Europe gateway guide →
Any 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 →