Non-EU seller? Find out which of the four regimes require an EU Authorized Representative, what it costs per year, and which vetted EEA-established providers cover your category.
Rules and provider pricing verified 2026-06-09.
Determination pending — complete the form
Rules dataset version 2026.06.09
You need an EU Authorized Representative.
GPSR (Reg 2023/988)
Reg (EU) 2023/988, Art. 16
REQUIRED
MDR / IVDR (Reg 2017/745)
Reg (EU) 2017/745, Art. 2
NOT APPLICABLE
Reg 2019/1020
Reg (EU) 2019/1020, Art. 4(1)(d)
Your fulfilment provider may decline this role — verify in writing.
Reg 2019/1020 Art. 4(1)(d): your fulfilment service provider becomes the responsible person by default — most FSPs decline this role. Appoint an AR in writing.
This is a regulatory triage estimate — not legal advice. For required or advisory-review outcomes, consult qualified EU compliance counsel before placing goods on the EU market.
This result is based on Regulation (EU) 2023/988 GPSR Art 15-17 + Regulation (EU) 2017/745 MDR Art 11 as published. Rules can change; this tool may not reflect the latest amendments. Verify with the official source before acting on this result.
This site provides general information about Regulation (EU) 2023/988 GPSR Art 15-17 + Regulation (EU) 2017/745 MDR Art 11. It is not legal advice and does not create a professional relationship. We are not lawyers. For decisions affecting your business, consult a qualified professional in your jurisdiction. Information may be outdated; verify against official sources. Last updated: 2026-06-09.