Market Surveillance Regulation

The EU's enforcement framework for product rules. Its Article 4 is the practical blocker for online sellers: since 16 July 2021, most CE-marked goods can only be placed on the EU market if an economic operator established in the EU is responsible for compliance tasks — and that operator's contact details must accompany the product.

Read the official text

Applies to

Products subject to EU harmonisation legislation. Article 4 specifically applies to products covered by a defined list of CE legislation — including toys, electromagnetic compatibility, machinery, PPE, gas appliances, construction products, pressure equipment and more — regardless of the sales channel (including direct online sales from outside the EU).

Key obligations

01A product covered by the Article 4 list may only be placed on the EU market if there is an economic operator established in the Union responsible for the Article 4 tasks (applies since 16 July 2021).source
02That operator can be: the manufacturer established in the EU; an importer (where the manufacturer is not established in the EU); an authorised representative with a written mandate; or an EU-established fulfilment service provider handling the products (Article 4(2)).source
03The operator's tasks (Article 4(3)): verify that the EU Declaration of Conformity and technical documentation exist and keep the DoC available; provide information and documentation to authorities on request; inform authorities when a product presents a risk; cooperate on corrective action.source
04The name, registered trade name or trade mark and contact details (including postal address) of the Article 4 operator must be indicated on the product or on its packaging, the parcel or an accompanying document (Article 4(4)).source

Conformity routes

Not a conformity-assessment lawThe MSR adds no assessment modules of its own — it gives surveillance authorities powers (information requests, inspections, sampling, sales restrictions) and imposes the Article 4 responsible-operator condition on top of the sectoral CE legislation.source

Documentation

Written mandate (when using an authorised representative)The authorised representative must hold a written mandate covering the Article 4 tasks.source
EU Declaration of Conformity + technical documentation availabilityThe EU operator must be able to verify these exist and produce them for authorities on request.source

Marking requirements

Indicate the EU responsible operator's name/trade mark and contact details including postal address on the product, its packaging, the parcel or an accompanying document (Article 4(4)). This is in addition to the manufacturer/importer markings required by the sectoral CE legislation.source

Key dates

2021-07-16Article 4 applies: products in scope may no longer be placed on the EU market without an EU-established responsible economic operator.source

Penalties

Member States lay down penalty rules for infringements (Article 41); authorities can also order corrective action, restrict marketing, and require removal of online listings.source

Further guidance

Frequently asked

I sell CE-marked products online from outside the EU — do I need someone in the EU?+

Yes, for products on the Article 4 list (most CE-marked consumer goods). Since 16 July 2021 they can only be placed on the EU market if an EU-established economic operator — importer, authorised representative or fulfilment service provider — is responsible for the compliance tasks, and their details must accompany the product.

Does using an EU fulfilment centre satisfy Article 4?+

It can: an EU-established fulfilment service provider handling your products may act as the Article 4 operator where there is no EU manufacturer, importer or authorised representative. But the provider must actually accept and perform the compliance tasks — it doesn't happen automatically by warehousing.

What must the EU responsible person actually do?+

Verify that the EU Declaration of Conformity and technical documentation exist, keep the DoC available for authorities, provide information on request, inform authorities if a product presents a risk, and cooperate on corrective actions. Their name and postal address must appear on the product, packaging, parcel or accompanying document.

How does this relate to the GPSR responsible person?+

The GPSR extended the same concept beyond CE goods: since 13 December 2024 all consumer products need a responsible economic operator in the EU. For CE-marked products, Regulation 2019/1020 Article 4 is the original source of the requirement — one EU operator can fulfil both roles.

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