EU market surveillance · Reg (EU) 2019/1020, Art 4
Does your product need an EU Article 4 operator?
For products under the listed Union harmonisation acts, there must be an economic operator established in the EU who holds the EU Declaration of Conformity and makes the technical documentation available to a market surveillance authority on request. Find who that operator is — and whether one is missing.
The rule, in one line
Under Regulation (EU) 2019/1020 (applies since 16 July 2021), a market surveillance authority can demand from an economic operator the EU declaration of conformity and the technical documentation needed to demonstrate a product's conformity. For products covered by the listed Union harmonisation acts, Article 4 additionally requires an economic operator established in the EU — under the Art 4(5) waterfall: a manufacturer established in the Union; failing that the importer; failing that an authorised representative with a written mandate; failing that a fulfilment service provider established in the Union. That operator keeps the declaration at the authority's disposal and makes the technical documentation available on a reasoned request, in a language the authority easily understands.
Official sources: Regulation (EU) 2019/1020 · Commission Art 4 guidance · Consolidated text (Art 4 scope)
Article 4 verdict
An EU Article 4 operator is required
This product is covered by an act in the Article 4 scope list, so an economic operator established in the EU must hold the EU declaration of conformity and make the technical documentation available to a market surveillance authority on request.
What an authority may request
- Responsible operator (Art 4(5) waterfall): the manufacturer established in the EU — they perform the Article 4 tasks.
- On a reasoned request, provide the declaration of conformity and the technical documentation in a language the authority easily understands; keep the declaration at its disposal for the period the underlying act requires; and inform the authorities if you have reason to believe the product presents a risk (Art 4(3)).
Per-product pack
Market surveillance pack (PDF) · €29
A print-ready pack for one product: the Article 4 scope verdict, the responsible-operator waterfall, the documentation an authority may demand (Art 4(3)), the gap flags, and source links — for your compliance file.
This is guidance, not legal advice. It states no retention period (set by the underlying act) and no penalties (set by national law); confirm those for your product.
What this tool is — and isn't
This checker routes the Article 4 economic-operator position by legislation and supply-chain role under Regulation (EU) 2019/1020, using EUR-Lex + the Commission's Article 4 guidance. The Article 4 scope list is a dynamic, date-stamped lookup — the Commission cites 18 acts but the consolidated text already adds later ones (e.g. batteries Reg (EU) 2023/1542), so the scope here is current as of the verified date only. It does not state a documentation-retention period (set by each underlying act, not by 2019/1020) or penalties (set by national law, Art 41). It does not establish (non-)compliance. It is an estimate and orientation, not legal advice. Verify against the linked official sources.
How the determination works
1. Is the act in Article 4 scope?
Article 4 applies only to products covered by a listed Union harmonisation act. The tool maps your act to that list, kept as an editable, date-stamped lookup because the list is amended over time. Acts outside it still face the general doc-on-request duty.
2. Who is the responsible operator?
Article 4(5) sets a waterfall: a manufacturer established in the EU; failing that the importer; failing that an authorised representative with a written mandate; failing that a fulfilment service provider in the EU. If none exists in the EU, the required operator is missing.
3. What must they hold and supply?
Under Article 4(3) the operator keeps the declaration of conformity at the authority's disposal, makes the technical documentation available on a reasoned request in an easily-understood language, and informs the authorities of any risk. The tool flags a documentation gap if you can't produce these.
Frequently asked questions
- What is an Article 4 economic operator?
- For products covered by listed Union harmonisation acts, Article 4 of Reg (EU) 2019/1020 requires an economic operator established in the EU — a manufacturer, importer, authorised representative or fulfilment service provider — who holds the declaration of conformity and makes the technical documentation available to market surveillance authorities.
- Which products need one?
- Those covered by an act in the Article 4 scope list (toys, machinery, EMC, LVD, radio, PPE, gas, construction, RoHS, pyrotechnics, recreational craft, measuring instruments, ATEX, pressure equipment, outdoor noise, ecodesign, batteries, and more). The list is amended over time, so re-check.
- What is the order of responsibility?
- Article 4(5) sets a waterfall: the manufacturer established in the EU; failing that the importer; failing that an authorised representative with a written mandate; failing that a fulfilment service provider in the EU.
- Am I covered as a distributor or online seller?
- Distributors and online sellers are not Article 4 operators, but they have their own duties under sectoral legislation and Reg (EU) 2019/1020 — and a product still needs an Article 4 operator somewhere in the EU.
- How long must documents be kept?
- Reg (EU) 2019/1020 itself does not set a retention period — the declaration is kept 'for the period required by that legislation', i.e. by the underlying act for your product. This tool does not assert a fixed number of years; check your specific act.
- Is this legal advice?
- No. This tool routes the Article 4 position from the legislation and role you provide; the scope list is a date-stamped lookup, and it states no retention period or penalties. It is orientation, not legal advice. Verify against the linked official sources.