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Manufacturer obligations

Last reviewed: October 2026 · Sources listed at the end of this page.

The manufacturer is the primary responsible party in EU product law. Under Decision No 768/2008/EC, Annex I, Article R1(3), a manufacturer is "any natural or legal person who manufactures a product or has a product designed or manufactured, and markets that product under his name or trademark". The definition is functional: it does not depend on whether the entity owns the factory, performs the design, or carries out the conformity assessment in person. An economic operator that brands a product as its own — including a "private label" reseller — becomes the manufacturer for the purposes of EU harmonisation legislation, regardless of where the physical production occurs.

The manufacturer's obligations apply for the life of the product and beyond — typically ten years after the last unit is placed on the market, with sector-specific exceptions running to fifteen years for implantable medical devices. The page importer obligations covers the parallel duties of EU-established importers, and authorised representative covers the appointment of an EU contact by manufacturers established outside the Union.

At a glance. The manufacturer designs and builds to the essential requirements, completes the conformity assessment, keeps the technical file, signs the EU Declaration of Conformity and affixes the CE mark. These duties are in force today and apply equally to manufacturers outside the EU. Whether a Notified Body is needed depends on the act and the route: see when you need a Notified Body. Key date: for products placed on the market after 9 December 2026, the new Product Liability Directive applies.

Legal basis

The main obligations under Article R2

Article R2 of Decision 768/2008/EC has nine paragraphs, which break down into the steps below. The aligned sectoral acts repeat them, sometimes with additions, and fix the periods the Decision leaves open:

  1. Design and manufacture the product in accordance with the essential requirements set out in the applicable act when placing it on the market.
  2. Draw up the required technical documentation and carry out, or have carried out, the applicable conformity assessment procedure. The technical file must be kept for the period set by the sectoral act, commonly ten years after the product was placed on the market.
  3. Draw up an EU Declaration of Conformity on the basis of the technical file (EU Declaration of Conformity).
  4. Affix the CE marking to the product or its data plate or, where that is not possible or not warranted, to the packaging and accompanying documents, in accordance with Article 30 of Regulation 765/2008 and Article R12 (affixing the CE mark).
  5. Ensure procedures are in place for series production to remain in conformity. Changes in product design, in the applicable harmonised standards, or in production processes that affect conformity must be adequately taken into account.
  6. Where appropriate to the risks presented, carry out sample testing of products made available, investigate, and keep a register of complaints, of non-conforming products, and of product recalls, and keep distributors informed of any such monitoring (Article R2(4) of Decision 768/2008/EC).
  7. Ensure traceability: indicate on the product or, where this is not possible, on the packaging or accompanying documents, a type, batch or serial number or other element allowing identification.
  8. Indicate identity and contact details on the product or, where this is not possible, on the packaging or accompanying documents: name, registered trade name or trade mark, and the postal address at which the manufacturer can be contacted. A single contact point must be provided.
  9. Provide instructions and safety information in a language easily understood by consumers and other end-users, as determined by the Member State concerned.
  10. Take corrective measures when there are reasons to believe a product on the market is not in conformity. Where the non-conformity presents a risk, inform the competent national authorities of the Member States in which the product was made available, giving details of the non-conformity and any corrective measures taken.
  11. Cooperate with competent national authorities, on reasoned request, by providing all information and documentation necessary to demonstrate the conformity of the product, in a language easily understood by the authority. Cooperate on any action taken to eliminate risks posed by products placed on the market.

Who counts as the manufacturer

Three situations require attention:

Private label and OEM relationships

Under Article R6 of Decision 768/2008/EC, an importer or distributor that places a product on the market under its own name or trademark, or modifies a product already on the market in a way that affects compliance, is treated as the manufacturer and assumes the full Article R2 obligations. The rebrander takes entire responsibility for the conformity assessment, even if someone else carried it out. According to the Blue Guide (section 3.1), it must possess all the documentation and certificates needed to demonstrate conformity. These need not be in its name, but it must be clear that they cover the specific product placed on the market. Check the applicable act and ask the Notified Body how any certificate should be handled.

Contract manufacturing

Where one entity designs the product and another performs the physical manufacturing, the manufacturer for CE purposes is the one that markets it under its own name or trademark. The contract manufacturer's obligations are governed by the commercial contract; the brand owner remains the legal manufacturer under EU law.

Substantial modification

A product on the market that is substantially modified after first placing on the market triggers a fresh placing on the market and a fresh conformity assessment. The party making the modification becomes the manufacturer for the modified product. The Blue Guide 2022 (section 2.1) treats a product as new, case by case, if its original performance, purpose or type is modified in a way not foreseen in the initial risk assessment, the nature of the hazard has changed or the level of risk has increased, and the product is made available or, where the act covers it, put into service.

The "economic operator established in the Union" obligation

Since 16 July 2021, Article 4 of Regulation (EU) 2019/1020 has required that for products covered by 18 listed Union harmonisation acts (including LVD, EMC, Machinery, PPE, Toy Safety, RoHS, RED, and the Construction Products Regulation) an economic operator established in the Union must be in place to perform specified tasks:

If the manufacturer is established in the EU, it performs these tasks itself. If not, the role is filled by an importer, by an authorised representative holding a written mandate for these tasks or, where no such operator is established in the Union, by an EU-established fulfilment service provider for the products it handles (Article 4(2)). That operator's name and contact details, including a postal address, must appear on the product, its packaging, the parcel or an accompanying document (Article 4(4)).

Sectoral additions

Several sectoral acts impose obligations beyond Article R2:

Medical Devices Regulation (EU) 2017/745, Article 10

Adds: post-market surveillance system (Article 83); a quality management system (Article 10(9)); Periodic Safety Update Report for Class IIa, IIb, and III devices (Article 86); registration of the manufacturer in EUDAMED (Article 31); Person Responsible for Regulatory Compliance (PRRC) under Article 15; measures, proportionate to risk class, device type and enterprise size, providing sufficient financial coverage for potential liability (Article 10(16)).

Machinery Regulation (EU) 2023/1230, Article 10

Applies from 20 January 2027. Adds: assembly instructions (Annex XI) and a separate EU declaration of incorporation (Article 11, Annex V Part B) for partly completed machinery; availability of source code or programming logic to authorities on reasoned request where necessary to check compliance (Article 10(3)); protection against corruption and other software-related essential requirements under Annex III (section 1.1.9).

Toy Safety Regulation (EU) 2025/2509, Article 7

Adds: a safety assessment covering chemical, physical, mechanical, electrical, flammability, hygiene and radioactivity hazards (Article 25); a Digital Product Passport for each toy (Articles 7(2) and 19–21); upload of the toy's unique identifiers to the digital product passport registry (Article 22). These obligations apply from 1 August 2030, when the Regulation applies in full (Article 59).

General Product Safety Regulation (EU) 2023/988, Article 9

Article 9 applies to consumer products not covered by harmonisation legislation; it does not apply to CE-marked products (Article 2(1)). Those products are, however, subject to the distance-selling information in Article 19, the accident notification duty through the Safety Business Gateway in Article 20, and the marketplace rules in Chapter IV. For risks the sectoral act does not cover, the GPSR safety requirements in Chapter II also apply.

Corrective and informational duties

The manufacturer's obligation to take corrective measures (Article R2(8) of Decision 768/2008/EC) operates in three steps:

  1. Investigation upon receipt of evidence — through complaints, monitoring, accident reports — that a product on the market may not be in conformity.
  2. Corrective action proportionate to the risk: bringing into conformity, withdrawing from the market, or recalling.
  3. Notification of competent authorities of the Member States in which the product was made available where the non-conformity presents a risk. Notification is to be done immediately, with detailed information about the non-conformity, the corrective measures taken, and the affected serial numbers or batches.

The EU Safety Gate (formerly RAPEX) is the rapid alert system through which national authorities notify dangerous products to other Member States and the Commission (Regulation (EU) 2023/988, Articles 25–26). Businesses report through the separate Safety Business Gateway portal.

Cooperation with market surveillance authorities

On reasoned request, the manufacturer must provide all information and documentation necessary to demonstrate conformity. The period for response is set by the requesting authority, taking into account the urgency and the nature of the request. The documentation must be in a language easily understood by the authority; the authority may accept a language other than its national language.

Manufacturers established outside the Union meet these obligations through their EU-established economic operator (authorised representative, importer, or fulfilment service provider under Article 4 of Regulation 2019/1020). Direct extraterritorial enforcement against non-EU manufacturers is limited; the EU operator is the practical enforcement target.

Common errors

Relationship to other economic operators

The manufacturer's responsibility does not eliminate the duties of importers and distributors but it remains the primary one. The chain works as follows:

Where multiple operators are non-compliant, market surveillance authorities may proceed against each. The manufacturer remains the operator with the underlying obligation to bring the product into conformity.

Civil liability is changing. Directive (EU) 2024/2853 repeals Directive 85/374/EEC with effect from 9 December 2026 and applies to products placed on the market or put into service after that date. Older products stay under the 1985 rules. Where the manufacturer is outside the Union, the new Directive makes the importer and the authorised representative liable as well and, where there is neither, the fulfilment service provider (Article 8).

Frequently asked questions

Am I the manufacturer if a factory makes the product for me?

Yes, if you market it under your own name or trademark. You carry the full manufacturer obligations even if the factory did the design, testing and production.

Can I rely on my supplier's CE certificates for an own-brand product?

You can use them as evidence, and the Blue Guide says documents need not be in your name, but you must possess everything needed to demonstrate conformity and it must be clear that it covers your specific product. Responsibility for conformity stays with you.

How long must a manufacturer keep the technical file?

For the period set by the sectoral act, commonly ten years after the product was placed on the market. Implantable devices under the Medical Devices Regulation have fifteen years.

Do manufacturers outside the EU have different obligations?

No. The obligations are the same wherever the manufacturer is established. For products under the acts listed in Article 4(5) of Regulation 2019/1020, an economic operator established in the Union must also be in place.

Sources

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