NordMDR AB acts as EU Authorized Representative for manufacturers from the USA, UK, China, Japan, India, Australia and all non-EU countries. Legally required under EU MDR Article 11. Sweden-based. All 27 EU member states covered under one agreement.
Under EU MDR 2017/745 Article 11, every manufacturer established outside the European Union must appoint an EU Authorized Representative before placing a single medical device on the European market. This is a legal requirement with no exceptions — it applies to manufacturers from the USA, UK, China, Japan, India, Australia and every other non-EU country.
Your EU AR acts as your legal address in Europe. They handle EUDAMED registration on your behalf, communicate with Competent Authorities, and share legal responsibility for the safety and compliance of your devices. Without a registered EU AR, your products cannot be sold in any of the 27 EU member states.
EU MDR uses four classes: I, IIa, IIb, and III. Class determines documentation requirements and whether a Notified Body is needed.
Product description, intended purpose, labelling and a preliminary risk assessment before signing the AR agreement.
A formal contract between you and NordMDR AB defining responsibilities, liability and the products covered.
NordMDR AB registers your company as a manufacturer and all your devices in EUDAMED. Mandatory from 28 May 2026.
With documentation complete and EUDAMED registered, you can affix the CE mark and sell legally across all 27 EU member states.
NordMDR AB — Sweden-based, all 27 EU member states, fixed fees, onboarding in 5 business days.
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