If you manufacture medical devices outside the European Union and want to sell them in Europe, you are legally required to appoint an EU Authorized Representative (EU AR) before a single unit can enter the market. This applies to manufacturers from the USA, UK, China, Japan, India, Australia, Canada, Turkey, Israel — anywhere outside the EU. It is a hard legal requirement under EU MDR 2017/745 Article 11, not optional guidance.
An EU AR is a company or individual legally registered in an EU member state who acts as your official representative in Europe. Their role is to:
Think of the EU AR as your legal address in Europe. Without one, your products cannot legally be placed on the market in any of the 27 EU member states — regardless of how good your products are.
You need an EU AR if your company is established outside the European Union and you want to sell medical devices in any EU country. This includes post-Brexit United Kingdom manufacturers — the UK is no longer part of the EU so UK manufacturers now need an EU AR just like any other non-EU manufacturer.
EU MDR uses four risk classes: Class I (lowest risk), Class IIa, Class IIb, and Class III (highest risk). Most simple devices fall into Class I or IIa. The class determines how much documentation is required and whether a Notified Body must be involved.
Before appointing an AR you need at minimum: a product description and intended purpose, basic labelling in the language of the target country, and a preliminary risk assessment. Your AR will help identify any gaps.
A formal written contract between you (the manufacturer) and your EU AR. It must define the products covered, the responsibilities of each party, liability arrangements, and how the relationship can be terminated.
Your EU AR registers your company as a manufacturer and registers each of your devices in EUDAMED. Both the manufacturer and the AR receive an SRN (Single Registration Number). Mandatory from Q1 2026.
Once your technical documentation is complete, your Declaration of Conformity is signed, and your EUDAMED registration is in place — you can affix the CE mark and sell legally across all 27 EU member states.
EU AR service fees vary significantly depending on the provider and the complexity of your product portfolio. Large global firms such as Emergo and Veranex typically charge €200–300 per hour with annual AR retainer fees of €5,000–15,000. These firms are designed for large manufacturers with big compliance budgets.
Smaller specialist firms like NordMDR AB offer flat-fee arrangements that are far more affordable for small and mid-size manufacturers — typically starting from €1,500–3,000 per year for a simple Class I device portfolio. This makes EU market access viable even for companies launching their first European product.
EUDAMED full mandatory registration is coming in 2026–2027. Any manufacturer or importer without a registered EU AR after the enforcement date faces immediate market suspension — your products will be removed from sale with no grace period. Competent Authorities in each member state have the power to enforce this immediately.
The complete registration process takes 4 to 8 weeks minimum. If you have not started yet, starting now gives you comfortable margin to meet the deadline without rushing.
Sweden is an EU member state with a strong medtech regulatory tradition and high credibility among European Competent Authorities. NordMDR AB is registered in Stockholm, Sweden as a fully compliant EU legal entity — providing the legal foundation your products need to access every EU market through a single AR agreement.
NordMDR AB provides EU AR services for manufacturers from anywhere outside the EU, covering all 27 member states. Based in Stockholm, Sweden. Fixed fees. Fast onboarding — operational within 5 business days.
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