How Non-EU Medical Device Manufacturers Get an EU Authorized Representative

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 is a hard requirement under EU MDR 2017/745 Article 11.

What is an EU Authorized Representative?

An EU AR is a company or individual registered in an EU member state who acts as your legal representative in Europe. They register your products in EUDAMED, handle Competent Authority communications, and share legal responsibility for your device compliance.

Step-by-step: How to appoint an EU AR

Step 1 — Classify your device. EU MDR uses four classes: I, IIa, IIb, and III. Class I and IIa devices have lower documentation requirements and are the most common starting point.

Step 2 — Prepare basic documentation. Product description, intended purpose, labelling, and a basic risk assessment are needed before signing an AR agreement.

Step 3 — Sign an EU AR agreement. A formal contract defining responsibilities and liability scope between you and your AR.

Step 4 — Register in EUDAMED. Your EU AR registers both your company and your devices. Mandatory from 28 May 2026.

Step 5 — Apply the CE mark and begin selling legally across all 27 EU member states.

How Much Does an EU Authorized Representative Cost?

EU AR fees vary based on device class, number of devices, and the scope of EUDAMED and Competent Authority services included. Typical market rates:

• Class I devices (low risk): €900–€1,800/year — lower documentation burden, no Notified Body involvement
• Class IIa / IIb devices: €1,500–€3,500/year — includes NB certificate liaison and vigilance reporting
• Class III devices (high risk): €2,500–€5,000+/year — complex PMS obligations, PSUR reviews, Competent Authority communications

NordMDR AB offers fixed-fee EU AR arrangements — no hidden costs, no hourly billing. The fee covers EUDAMED registration, SRN maintenance, Competent Authority correspondence, and annual vigilance reporting. Request a fixed-fee quote.

The 2026 deadline you cannot miss

EUDAMED mandatory registration comes into force 28 May 2026. Any manufacturer without a registered EU AR after this date faces immediate market suspension. The process takes 4 to 8 weeks so starting now is critical.

NordMDR AB provides EU Authorized Representative services for manufacturers across all 27 EU member states. Based in Sweden, we onboard new clients within 5 business days. Contact us for a free compliance assessment.