Is GPSR the same as MDR EC Rep?

No. GPSR applies to general consumer products. MDR Article 11 EC Rep applies to medical devices only. They are separate legal roles under different regulations.

EU Authorized Representative for Consumer Products (GPSR)

Q: Do I need an EU Authorized Representative for consumer products?

Yes. Under the EU General Product Safety Regulation (GPSR), manufacturers outside the EU must appoint an EU-based economic operator — typically an authorised representative or importer — before placing consumer products on the EU market.

Q: Does Amazon require a GPSR responsible person?

EU marketplace operators and platforms require non-EU sellers to identify a responsible economic operator in the EU with contact details on product labels and documentation, in line with GPSR obligations.

Medical Devices

EU MDR / IVDR EC Rep

Article 11 Authorized Representative · EUDAMED · Notified Body pathway · Class I–III

Consumer Products — You are here

GPSR Responsible Person

General Product Safety Regulation · Amazon & DTC · No EUDAMED · Non-medical goods

Not medical devices? This page covers GPSR consumer products. For MDR EC Rep see EU Authorized Representative (medical devices).

Why Your Consumer Brand Needs an EU Authorized Representative

Under the EU General Product Safety Regulation (GPSR) — in force since December 2024 — manufacturers established outside the European Union must have a designated EU economic operator before consumer products enter the EU market. This applies whether you sell on Amazon EU, Shopify, wholesale distributors, or your own website.

Without an EU Responsible Person / Authorised Representative, products risk market surveillance action, platform listing removal, border holds, and recalls. GPSR is separate from medical device rules — if you sell medical devices, you need MDR Article 11 EC Rep instead.

What NordMDR Provides — GPSR Services

EU Responsible Person appointment — Stockholm-based economic operator on your labels and documentation
Product safety assessments — review of conformity basis (CE marking where applicable, test reports, risk analysis)
Technical documentation review — GPSR product file, traceability, and incident readiness
Labelling compliance — manufacturer details, EU operator contact, product identifiers, warnings
Market surveillance contact — point of contact for EU authorities and platform compliance requests
Cross-sell to CE directives — electronics? See EMC & CE marking support

Who Needs GPSR EU Representative Services?

US, UK, and APAC e-commerce brands selling consumer goods into the EU
Amazon / marketplace sellers without an EU-established entity
Consumer electronics, home goods, toys, textiles, accessories — non-medical products
Brands that need one partner for GPSR + CE marking (EMC, LVD, RoHS as applicable)

GPSR vs MDR EC Rep — Quick Comparison

GPSR (this page): General consumer products · EU Responsible Person · No EUDAMED
MDR EC Rep: Medical devices & IVDs only · Article 11 · EUDAMED mandatory — learn more
CH-REP: Switzerland medical devices · MedDO — learn more

Frequently Asked Questions — GPSR Consumer Products

Do I need an EU Authorized Representative for consumer products?

Yes, if you are a non-EU manufacturer placing consumer products on the EU market. GPSR requires an EU-established economic operator with documented responsibilities.

Is this the same as medical device EC Rep?

No. GPSR and MDR are different regulations. NordMDR offers both — see our Authorized Representative services hub.

Does Amazon require a GPSR responsible person?

EU marketplaces require identifiable EU economic operator details on products and listings. A GPSR Responsible Person satisfies this requirement when properly appointed and labelled.

Need a GPSR EU Representative?

Fixed-fee onboarding for non-EU consumer brands. Stockholm-based. 2-hour response on urgent intakes.

Speak with a Stockholm-based consultant (2-hour response)

EU Authorized Representative for Consumer Products (GPSR Compliance)