EU Authorised Representative for CE-Marked Goods

Many CE-marked products cannot be placed on the EU market unless an economic operator established in the Union is responsible for them. Where a manufacturer outside the Union has no EU importer, it appoints an authorised representative to be that operator. Engage Compliance is established in the Union and takes the role, and keeps the technical file for as long as the law requires.

The short answer: under Article 4 of Regulation (EU) 2019/1020, a product within its scope may be placed on the EU market only if an economic operator established in the Union is responsible for it. For a manufacturer outside the Union with no EU importer, an authorised representative under a written mandate can be that operator. The authorised representative is defined in Article R3 of Annex I to Decision No 768/2008/EC, and it is the role Engage Compliance takes for CE-marked goods, holding the technical file behind it.

The distinctive thing about this obligation is its length. The appointment is straightforward; the custody of the technical file that comes with it runs for ten years after a product is placed on the market, and that is the part worth choosing carefully.

Key takeaways

Article 4 of Regulation (EU) 2019/1020 means many CE-marked products cannot be placed on the EU market unless an economic operator established in the Union is responsible for them.
The authorised representative is defined in Article R3 of Annex I to Decision No 768/2008/EC: a person established in the Union holding a written mandate to act for the manufacturer on specified tasks.
The four tasks under Article 4(3) are to keep the declaration of conformity and technical documentation available, to provide conformity information on request, to inform authorities of a risk, and to cooperate on corrective action.
Article 4(4) requires the responsible operator’s contact details to appear on the product, its packaging, the parcel, or an accompanying document.
There is no qualification, registration, professional body membership, or insurance requirement. The only condition is establishment in the Union.
The technical documentation is kept available for ten years after the product is placed on the market, which is why the role is a continuity decision rather than a price one.
Great Britain and the UKCA mark are a separate regime and not covered. Northern Ireland is covered by the same EU appointment.

What an authorised representative is

The EU’s harmonised product legislation, the New Legislative Framework, is built from a common template set out in Decision No 768/2008/EC. Article R3 of its Annex I defines the authorised representative as a natural or legal person established within the Union who has received a written mandate from a manufacturer to act on its behalf in relation to specified tasks. That definition is carried, in the same or near-identical words, into the individual CE-marking regimes, from the Toy Safety Directive to the regulations on electromagnetic compatibility, radio equipment, and personal protective equipment.

Regulation (EU) 2019/1020 then adds the reachability rule. Its Article 4 says that for the products within its scope, none may be placed on the EU market unless there is an economic operator established in the Union responsible for the Article 4(3) tasks. An authorised representative under a Decision 768/2008 mandate can be that operator. Put together: the authorised representative is a mandated EU stand-in for the manufacturer, and, for products caught by Article 4, the operator whose existence lets a non-EU manufacturer sell a CE-marked product into the EU at all.

Which products are caught

Article 4 of Regulation (EU) 2019/1020 applies to products covered by the Union harmonisation legislation listed in its Annex I. That list is broad and covers many of the everyday CE-marking regimes: toys, low-voltage electrical equipment, electromagnetic compatibility, radio equipment, personal protective equipment, gas appliances, and others. If your product carries a CE mark under one of those regimes, and you have no EU establishment and no EU importer, Article 4 requires a responsible operator, and the authorised representative role fills it.

Not every product is inside Article 4, and the honest first step is to confirm your product is caught before appointing anyone. Where a product is a general consumer product rather than a CE-marked one, the relevant obligation is the GPSR responsible person role under the General Product Safety Regulation instead. We will tell you which one applies to you.

Who can hold the role

Article 4(2) of Regulation (EU) 2019/1020 sets the order. The responsible operator is a manufacturer established in the Union; or an importer, where the manufacturer is not in the Union; or an authorised representative holding a written mandate; or, where none of those exists, a fulfilment service provider established in the Union. A non-EU manufacturer selling CE-marked goods into the EU with no EU importer is in the third line and appoints an authorised representative. Engage takes that role.

The four tasks, and the limit on the mandate

Article 4(3) gives the responsible operator four duties:

Keep the paperwork available. Verify that the EU declaration of conformity and the technical documentation exist, and keep them at the disposal of market surveillance authorities.
Answer on request. Provide authorities, on a reasoned request, with the information and documentation to demonstrate conformity, in a language they can readily understand.
Flag a risk. Inform the authorities where there is reason to believe the product presents a risk.
Cooperate on corrective action. Work with the authorities on any action to eliminate or mitigate a risk.

There is a real limit on what a manufacturer can hand over. Article R3 of Decision 768/2008 lets the manufacturer delegate the tasks specified in the mandate, but the manufacturer’s own core obligations stay with the manufacturer: drawing up the technical documentation, carrying out or arranging the conformity assessment, and affixing the CE mark. The authorised representative holds the file and is the EU contact; it does not become the manufacturer.

The contact details on the product

Under Article 4(4), the name and contact details of the responsible operator must be indicated on the product, or on its packaging, the parcel, or an accompanying document. We supply the exact wording and the contact point to place there, so a consumer or an authority always has a reachable EU operator to address.

No qualification, no registration, no insurance

There is no qualification requirement, no registration, no professional body membership, and no insurance requirement for this role. The only condition is establishment in the Union. When the law asks for no credential, what separates a dependable authorised representative from a fragile one is continuity: whether it will still be established and still holding your technical file years after the product shipped.

The ten-year file, against the annual contract

The technical documentation is kept available for ten years after the product is placed on the market. The role is commonly sold on one-year contracts, and those two facts do not fit together. A decade-long custody duty does not fit a contract you renew each year, and if the chain breaks, a product is left on the EU market with no responsible operator, which is the state Article 4 exists to prevent. So the question to put to any provider is whether it will still be there, with the file current, in year seven. We take the role on that basis, and we hold the technical file and the declaration of conformity for the full period rather than for the length of a contract.

Northern Ireland is covered, Great Britain is separate

Great Britain runs its own product regime and its own UKCA marking, and Engage does not currently offer a Great Britain product-side service. Northern Ireland is covered: the EU rules apply there, and the UK Office for Product Safety and Standards confirms that a single responsible economic operator can serve both the EU and Northern Ireland, regardless of which of the two it is established in. The EU appointment we provide covers both, so you do not need a separate operator for Northern Ireland.

What Engage delivers

The appointment, as your authorised representative under a written mandate that meets Article R3 of Decision 768/2008 and the Article 4(2) requirement.
A named EU contact point for market surveillance authorities, in the form you put on the product or its documentation under Article 4(4).
Custody of the technical file. We hold the declaration of conformity and technical documentation and keep them available for the ten-year period, and we tell you what is missing rather than assuming it is complete.
Handling of authority contact, with requests answered, the substance passed to you, and corrective action coordinated where needed.
A scoping check first. If your product is not within Article 4, or you already have an EU importer, you may not need an authorised representative, and we will say so.

What it costs

Pricing is scoped to the mandate, because it depends on the product, the regime it is CE-marked under, and where your technical file sits today. Tell us what you place on the EU market and we will scope it. You can reach us through the contact page.

What we do not offer, and why

Medical device authorised representation. We do not act as an authorised representative under the Medical Device Regulation, Regulation (EU) 2017/745, or the In Vitro Diagnostic Regulation, Regulation (EU) 2017/746. MDR Article 15 requires a person responsible for regulatory compliance with defined qualifications, and MDR Article 11(5) makes the representative jointly and severally liable with the manufacturer for defective devices. That is a different role, and we route those enquiries to a partner.
CBAM representation. We do not act under the Carbon Border Adjustment Mechanism, which requires authorisation as an indirect customs representative.
A Great Britain product-side service. Great Britain and the UKCA mark are a separate regime we do not cover. Northern Ireland is covered by the EU mandate.

Sources and references

Representative mandates

These mandates stack rather than replace each other. One company selling into Europe can be caught by several at once, each is a separate appointment with its own published contact point, and an EU representative does not cover the UK. Engage Compliance holds them together so you have one point of contact across the set.

Established in the Union
Ten-year technical file custody
Named EU contact for market surveillance

Talk to us

FAQ

Frequently asked questions

What is an EU authorised representative for CE-marked goods?

It is a natural or legal person established in the Union who holds a written mandate from a manufacturer to act on its behalf in relation to specified tasks, as defined in Article R3 of Annex I to Decision No 768/2008/EC, the template the EU's harmonised product legislation is built on. For products within the scope of Article 4 of Regulation (EU) 2019/1020, that authorised representative can be the economic operator responsible for the product on the EU market, which is what lets a non-EU manufacturer with no EU importer place CE-marked goods on the market lawfully.

Which products need a responsible operator in the EU?

Article 4 of Regulation (EU) 2019/1020 applies to products covered by the Union harmonisation legislation listed in its Annex I, which spans many CE-marking regimes, including toys, electrical equipment, electromagnetic compatibility, radio equipment, personal protective equipment, and others. For those products, none may be placed on the EU market unless an economic operator established in the Union is responsible for the Article 4(3) tasks. If your product carries a CE mark under one of those regimes and you have no EU establishment or importer, you need a responsible operator, and an authorised representative can be it.

What does the authorised representative actually do?

The mandate must let it carry the tasks in Article 4(3) of Regulation (EU) 2019/1020: keep the EU declaration of conformity and the technical documentation available to market surveillance authorities; provide, on request, the information and documentation to demonstrate conformity; inform authorities where a product presents a risk; and cooperate on corrective action. Article R3 of Decision 768/2008 sets the floor of what a manufacturer must be able to delegate. What the representative cannot take on is the manufacturer's own core duties, such as drawing up the technical documentation and carrying out the conformity assessment.

Does the authorised representative need a qualification, registration, or insurance?

No. There is no qualification requirement, no registration, no professional body membership, and no insurance requirement. The only condition is establishment in the Union. So the thing that distinguishes one authorised representative from another is not a credential but continuity: whether it will still hold your technical file when an authority asks in year eight.

How long is the technical file kept?

Ten years after the product is placed on the market. The authorised representative keeps the technical documentation and the declaration of conformity available to authorities for that period. That decade-long duty is why the role is a continuity decision, not a price decision: the file has to survive well beyond any single annual contract.

Does this cover Great Britain and the UKCA mark?

No. Great Britain runs its own regime and its own UKCA marking, and Engage does not currently offer a Great Britain product-side service. Northern Ireland is different: the EU rules apply there, and the UK Office for Product Safety and Standards confirms a single responsible economic operator can serve both the EU and Northern Ireland regardless of which of the two it is established in, so one EU appointment covers both.