NordMDR AB is an EU MDR consultant in Sweden helping non-EU manufacturers enter the European market without costly compliance mistakes. As your Stockholm-based EU Authorized Representative, we handle technical documentation, CE marking, and EUDAMED registration so you can focus on your business.
You built a great product. We handle everything standing between it and the European market — so you reach your customers faster, with zero compliance surprises.
Mandatory legal appointment under EU MDR Article 11 for all non-EU manufacturers. We handle all Competent Authority communication and EUDAMED registration on your behalf.
Required for non-EU manufacturersComplete preparation of Technical Files and Design Dossiers under Annex II and III — risk management, clinical evaluation, post-market surveillance plans and more.
Class I · IIa · IIb · IIIWe audit your documentation against EU MDR requirements and deliver a clear compliance roadmap with prioritised actions, realistic timelines, and fixed cost estimates.
Free initial checkFull electromagnetic compatibility testing support, pre-compliance assessments, technical file preparation and CE marking for electronic products sold in the EU and UK.
All product categoriesISO 26262 automotive functional safety compliance, IEC 61508 industrial safety, safety case development, FMEA, and hazard analysis for safety-critical systems.
Automotive · IndustrialFull actor and device registration in EUDAMED — mandatory from Q1 2026. We handle SRN acquisition, device registration, UDI entries, and annual maintenance updates.
2026 deadlineNordMDR AB is a regulatory affairs consultancy founded in Stockholm, Sweden with one goal: to make EU MDR compliance straightforward, predictable, and affordable for manufacturers and importers from anywhere outside the EU.
Based in Sweden and registered as a full EU legal entity, we serve as Authorized Representative for manufacturers and importers from anywhere outside the EU — USA, UK, China, Japan, India, Australia and beyond.
We specialise in working with small and mid-size businesses who need expert regulatory support without the costs of the global consulting giants.
Led by a regulatory affairs specialist with 20 years of hands-on medtech experience across EU MDR, CE marking, EMC compliance, and functional safety. Direct experience working with Competent Authorities, Notified Bodies, and manufacturers across medical devices, automotive, and industrial sectors in Europe and globally.
Practical guides and updates for manufacturers and importers navigating EU regulatory compliance.
More articles coming soon — contact us if you have a specific compliance question.
Under EU MDR 2017/745 Article 11, any manufacturer established outside the European Union must appoint an EU Authorized Representative before placing a single medical device on the European market. This applies to manufacturers from the USA, UK, China, Japan, India, Australia, Canada and every other non-EU country. NordMDR AB is a Stockholm-based EU MDR consultant providing this service across all 27 EU member states.
FDA clearance does not grant EU market access. Every US manufacturer needs a separate EU AR and must comply with EU MDR — a fundamentally different regulatory framework.
Learn more →Post-Brexit, UK manufacturers are treated as non-EU manufacturers. You need an EU AR to sell in Europe. UKCA marking does not cover the EU market.
Learn more →China, Japan, South Korea and Taiwan are major exporters of medical devices to Europe. Every manufacturer must have an EU AR before EUDAMED registration and CE marking.
Learn more →Not sure if you need an EU AR?
Check our EU MDR FAQ or contact us for a free 20-minute compliance check.
Tell us about your product and where you are stuck. We will come back to you within 24 hours with a clear, honest picture of exactly what you need — and what it will cost. No sales pitch. No obligation. Just clarity.
Whether you need an EU AR urgently, are blocked at customs, have a distributor waiting, or simply do not know where to start — we have seen it before and we know exactly how to fix it.
Thank you for reaching out. We have received your compliance assessment request and will get back to you within 24 hours.