Do you need an EU Authorized Representative?

A manufacturer or seller established outside the EU/EEA that places products on the EU market generally needs an EU-established responsible person. For products in scope of the General Product Safety Regulation (EU) 2023/988 that is the economic operator under Art. 16; for medical devices it is the sole authorised representative under MDR Art. 11; for products covered by Union harmonisation legislation it is the operator identified under Reg (EU) 2019/1020 Art. 4. If you already have an EU legal entity or an EU-established importer of record, the obligation may be covered without a separate AR — except for medical devices, where a sole AR is always required.

The General Product Safety Regulation (EU) 2023/988 started to apply on 13 December 2024, replacing the old General Product Safety Directive. Its Art. 16 means a consumer product may not be placed on the EU market unless an economic operator established in the Union is responsible for it — so non-EU sellers without an EU presence must appoint a responsible person. This is why many marketplaces began requiring a responsible-person address on listings during 2024–2025.

Often, yes — for GPSR (Art. 16) and for products under Reg (EU) 2019/1020 (Art. 4), an EU-established importer of record can satisfy the responsible-person duty. The important exception is medical devices: MDR Art. 11 requires a non-EU manufacturer to designate a sole authorised representative, and an importer cannot substitute for it. This tool flags that override automatically when you select a medical device or IVD category.

Not by default. Under Reg (EU) 2019/1020 Art. 4(2)(d), if no manufacturer, authorised representative or importer is established in the EU, a fulfilment service provider that handles the goods becomes the responsible person. In practice most fulfilment providers decline that role — Amazon ended its own Responsible Person service in 2024 — so relying on FBA or a 3PL to be your responsible person is a known compliance gap. Appoint an AR in writing rather than assuming the fulfilment provider covers it.

It depends on the regime and your volume. General product-safety / Reg 2019/1020 AR services typically start around €150–500 per year for low-volume sellers; medical-device sole AR services are materially higher (often €2,500–6,000+) because they include vigilance reporting and technical-documentation duties. This tool estimates a low–high range from the regimes that apply to you and your SKU count, and lists EEA-established providers; the figures are benchmarked against published vendor pricing, not a quote.

No. Cosmetic products have a separate Responsible Person under Regulation (EC) 1223/2009, with its own product-information-file and safety-assessment duties that general AR services do not cover. If you sell cosmetics, treat that as a distinct appointment; this tool surfaces a note when a cosmetics category is selected and filters to providers that offer the cosmetics RP role.

No. It is a deterministic triage estimator that maps your inputs to the EU regimes most likely in scope, citing the EUR-Lex source for each. It does not classify your specific product, draft any documentation, or certify compliance, and it carries a last-verified date that suppresses the verdict when the dataset goes stale. Use the result to brief a qualified EU compliance adviser, and verify against the live regulation before placing goods on the market.