Stockholm-based EU Rep under EU MDR Article 11 — also called EU AR, EAR, or Authorised Representative for medical devices and IVDs.
An EU Authorized Representative covers the 27 EU member states only. Switzerland requires a separate Swiss Authorised Representative (CH-REP) under MedDO — plus swissdamed registration. NordMDR provides both.
Swiss CH-REP Services → EU + Switzerland dual quoteNeed an EU Rep fast? NordMDR AB onboard EU Authorized Representatives within 5 business days. Speak with a Stockholm-based MDR consultant (2-hour response)
If you manufacture medical devices outside the European Union, you must appoint an EU Authorized Representative (EU Rep / EU AR) before placing products on the market. This is mandatory under EU MDR 2017/745 Article 11 — not optional, and not substitutable by a US FDA registration or UK MHRA registration alone.
MDR EU Rep (this page): Applies to medical devices and IVDs under EU MDR/IVDR Article 11. NordMDR AB provides this service from Stockholm.
Consumer products (GPSR): General consumer goods sold in the EU fall under the General Product Safety Regulation (GPSR) — a different EU responsible person framework, not MDR Article 11. Do not confuse the two roles.
Consumer products (GPSR): See our EU Authorized Representative for consumer products or the full Representative services hub. For electronics CE marking see EMC & CE marking.
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 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.
EU AR fees vary based on device class, number of devices, and the scope of EUDAMED and Competent Authority services included. Typical market rates:
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.
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 Rep and EU Authorized Representative services for manufacturers across all 27 EU member states. Pair with our EUDAMED registration and EU MDR consulting for a single Stockholm-based partner. Onboarding within 5 business days. Speak with a Stockholm-based MDR consultant (2-hour response)
An EU Rep (EU Authorised Representative) is your mandatory legal representative in the EU under MDR Article 11. The EU Rep registers you in EUDAMED, liaises with Competent Authorities, and coordinates vigilance — separate from your PRRC role under Article 15.
Yes, if you are a non-EU manufacturer placing medical devices on the EU market. This applies to US, UK, Chinese, Indian, and all other non-EU manufacturers regardless of FDA or UKCA status.
No. MDR EU Rep is for medical devices only. Consumer products require GPSR compliance and a different EU responsible person. NordMDR specialises in medical device EU Rep; for non-medical electronics see EMC CE marking.
They are the same role — your EU Authorised Representative under Article 11. Searchers use EU Rep, EU AR, EAR, and “authorized representative medical devices” interchangeably.
Your EU Rep registers as an economic operator in EUDAMED, obtains an SRN, and supports device registration. See our EUDAMED registration guide.
NordMDR AB provides EU Authorized Representative services, CE marking and EUDAMED registration for non-EU manufacturers. Stockholm-based. Fixed fees. 5-day onboarding.
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