The manufacturer role in EU product compliance
The manufacturer is the company that markets a product under its own name or trademark, whether it made the product itself or had it designed or made by someone else. EU product law gives the manufacturer the full set of duties: the risk analysis or conformity assessment, the technical documentation, the marking and the instructions, and action when a product turns out to be dangerous. A brand owner is the manufacturer even when a factory elsewhere builds the product.
Free account · no card · opens in the Demo Company
Reviewed 5 October 2026 by the Conphora compliance team · Not legal advice
Am I the manufacturer?
- Yes
A lamp you design and have built by a factory in Asia, sold under your brand
You have the product designed or manufactured and you market it under your own name. The factory is your subcontractor, and the manufacturer's duties are yours (GPSR Article 3(8)).
- Yes
A ready-made product that only carries your logo
A person who places a product on the market under its own name or trademark is deemed to be the manufacturer, also when only the label or the packaging was changed (GPSR Article 13(1); Low Voltage Directive Article 10).
- Yes
A product from another maker that you substantially modify
A person other than the manufacturer who substantially modifies a product is deemed to be a manufacturer for the part affected by the modification, or for the whole product if the modification affects its safety (GPSR Article 13(2)).
- No, you are the importer
A branded product from a maker outside the EU, sold under the maker's brand
The maker stays the manufacturer. You are established in the EU and place its product on the EU market, which makes you the importer. If the product was not designed or made for the EU market, the Commission's Blue Guide says you take on the manufacturer's role (section 3.1).
See the importer → - No, you are the distributor
A product bought from a supplier in the EU and sold on unchanged
Someone else already placed the product on the EU market. You make it available, which makes you a distributor, as long as it does not carry your own brand.
See the distributor →
What the law asks of you
The references name the General Product Safety Regulation (GPSR) and, as the example of a CE act, the Low Voltage Directive (LVD). For products under a product-specific harmonisation act, such as the Low Voltage or Toy Safety Directive, the GPSR's Chapter III, Section 1 (Articles 9 to 18) does not apply, and the act's own duties take its place (Article 2(1), third subparagraph, point (b)). The GPSR's safety requirement still covers risks the act does not (point (a)), and Articles 19 to 22, on online offers, accidents and online marketplaces, apply to all products, as do the recall rules in Articles 35 to 37. REACH restrictions and labelling rules do not take a product out of Articles 9 to 18. Whoever places on the EU market a product not designed for it, or a used product from outside the EU, takes on the manufacturer's role (Blue Guide, section 3.1); a used CE product resold inside the EU falls under the GPSR in full. The regulation guides list the article for each act.
Before the product is placed or sold
- Design and manufacture the product so that it is safe: under the GPSR in accordance with the general safety requirement, under a CE act such as the Low Voltage Directive in accordance with its safety objectives. GPSR Art. 5 and 9(1); LVD Art. 6(1)
- Carry out the risk analysis and draw up the technical documentation. Under a CE act, also carry out the conformity assessment, draw up the EU declaration of conformity and affix the CE marking. GPSR Art. 9(2); LVD Art. 6(2), 15, 16 and 17
- If you are established outside the EU, make sure that an economic operator established in the Union is responsible for the product before it is placed on the market. GPSR Art. 16(1); Regulation (EU) 2019/1020 Art. 4(1)
On the product and in the offer
- Put a type, batch or serial number on the product, together with your name, registered trade name or registered trade mark and your postal and electronic address (under the Low Voltage Directive, the postal address). Where the product's size or nature does not allow it, use the packaging or an accompanying document. GPSR Art. 9(5) and 9(6); LVD Art. 6(5) and 6(6)
- Supply clear instructions and safety information in the language determined by the Member State where the product is made available. GPSR Art. 9(7); LVD Art. 6(7)
Records to keep
- Keep the technical documentation, and for CE products the EU declaration of conformity, at the disposal of the market surveillance authorities for 10 years after the product was placed on the market. GPSR Art. 9(3); LVD Art. 6(3)
- Be able to say who supplied you and whom you supplied: for six years under the GPSR, for 10 years under the Low Voltage Directive. GPSR Art. 15; LVD Art. 11
While it is on the market
- Keep procedures in place so that series production stays in conformity when the design, the materials or the standards change. GPSR Art. 9(4); LVD Art. 6(4)
- Under the GPSR, offer public channels for complaints, investigate complaints and accident information, and keep an internal register of complaints, recalls and corrective measures. Under the Low Voltage Directive, where the risks warrant it, sample-test marketed equipment, investigate, keep a register of complaints, non-conforming equipment and recalls if necessary, and keep distributors informed. GPSR Art. 9(11) and 9(12); LVD Art. 6(4)
- When you sell online or at a distance, show in the offer the manufacturer's name and addresses, the responsible person where the manufacturer is outside the EU, the product identification with a picture, and the warnings. GPSR Art. 19
When something is wrong
- Under the GPSR, if a product you placed on the market is dangerous, act at once: take the corrective measures, including withdrawal or recall, inform consumers, and inform the market surveillance authorities through the Safety Business Gateway. Keep the other companies in your supply chain informed of safety issues. GPSR Art. 9(8) and 9(10)
- Under the Low Voltage Directive, if equipment you placed on the market does not conform, at once bring it into conformity, withdraw or recall it; where it presents a risk, at once inform the national authorities where you made it available. LVD Art. 6(8)
- Notify an accident caused by the product that resulted in death or serious adverse effects on health and safety through the Safety Business Gateway, without undue delay. This duty applies to CE products too. GPSR Art. 20(1) and 20(2)
- In a recall, notify the affected consumers you can identify directly, give written recall information as a recall notice with the content the GPSR lists, and offer the consumer a choice of at least two of repair, replacement and refund. These recall rules apply to CE products too. GPSR Art. 35(1), 36 and 37(2)
The name on the product decides who the manufacturer is. The General Product Safety Regulation (EU) 2023/988 defines the manufacturer as any person who manufactures a product or has it designed or manufactured, and markets it under its own name or trademark (Article 3(8)). A person who places a product on the market under its own name or trademark is deemed to be the manufacturer and is subject to the manufacturer's obligations (Article 13(1)). The Low Voltage Directive 2014/35/EU says the same for importers and distributors (Article 10).[1][2]
Which articles apply depends on the product. Consumer products without a product-specific act fall under Article 9 of the GPSR: an internal risk analysis, technical documentation kept for 10 years, an identifier and the manufacturer's name and addresses on the product, instructions and safety information, complaint channels and a register. For products covered by a CE act, Chapter III, Section 1 of the GPSR (Articles 9 to 18) does not apply (Article 2(1), third subparagraph, point (b)); the act itself sets the manufacturer's duties, for example the conformity assessment, the EU declaration of conformity and the CE marking under Article 6 of the Low Voltage Directive. The GPSR's rules on online offers and accidents (Articles 19 and 20) and its recall rules (Articles 35 to 37) still apply to those products. Whoever places on the EU market a product not designed or made for it, or a used product from outside the EU, takes on the manufacturer's role (Blue Guide, section 3.1).[1][2][5]
The manufacturer cannot pass the responsibility on. The Commission's Blue Guide states that a manufacturer who subcontracts design or production keeps the entire responsibility for the conformity assessment, and that it must have the documentation and certificates at its disposal even when somebody else produced them.[5]
A manufacturer established in the Union is also the economic operator responsible for the product towards the market surveillance authorities (Regulation (EU) 2019/1020, Article 4(2)(a); GPSR Article 16(1)). For products under the GPSR or the CE acts listed in Article 4(5) of that Regulation, a manufacturer outside the Union needs an importer, an authorised representative with a written mandate or, failing those, a fulfilment service provider in the Union to fill that role.[1][3]
What Conphora does for the manufacturer
What the platform does today for a company in this role.
The manufacturer's steps, product by product
The product workspace sets the role for each product and lists the steps that role carries under the regulations that apply to it.
Technical file assembly
The documents filed on a product are assembled into one technical file, so there is one document to send when an authority or a customer asks.
Declaration of conformity and product passport
The declaration is generated from the product's own data, and the product passport gives the product one page with its compliance information.
Supplier requests
Ask a supplier of parts or materials for test reports and declarations through one link. What comes back is filed on the product with the sender's name.
Radar and recall
Compliance Radar reports changes in the rules and Safety Gate alerts for your product types, and the recall manager runs a recall from the first alert to closure.
Who you share with
-
Importer
- You give
- The EU declaration of conformity; a copy of the technical documentation (GPSR) or, under a CE act, access to it when an authority asks; test reports, the product identification, instructions and safety information.
- You receive
- Requests for documents, the markets the product is sold in, complaints and accident information.
-
Distributor
- You give
- A marked product with instructions and safety information, and word of any safety issue you find.
- You receive
- Complaints, accident information and non-conformities found in the shop.
-
Authorised representative
- You give
- A written mandate that names the tasks, the declaration of conformity and access to the technical documentation.
- You receive
- Requests from authorities, and word when the representative has reason to believe a product is dangerous.
-
Market surveillance authorities
- You give
- The technical documentation and the declaration on request; notifications of dangerous products, corrective measures and accidents.
- You receive
- Reasoned requests, orders for corrective action, withdrawal or recall.
Regulations that bind the manufacturer
Taken from the regulation guides: 48 acts name this role. The article numbers are those of the role's duties in each act.
- GPSR General Product Safety Regulation Art. 5, 9, 15, 16, 19, 20, 35, 36 …
- MDR Medical Devices Regulation Art. 5, 7, 10, 10a, 11, 15, 18, 19 …
- IVDR In Vitro Diagnostic Medical Devices Regulation Art. 5, 6, 7, 10, 10a, 11, 15, 17 …
- BattR EU Batteries Regulation Art. 7, 8, 10, 11, 13, 14, 17, 18 …
- RED Radio Equipment Directive Art. 3, 3a, 4, 5, 10, 15, 17, 18 …
- PPWR Packaging and Packaging Waste Regulation Art. 4, 5, 6, 7, 9, 10, 11, 12 …
- PED Pressure Equipment Directive Art. 4, 6, 11, 12, 13, 14, 15, 17 …
- SPVD Simple Pressure Vessels Directive Art. 1, 4, 6, 11, 13, 14, 16, 38c
- PyroD Pyrotechnic Articles Directive Art. 6, 8, 9, 10, 11, 15, 17, 18 …
- RCD Recreational Craft Directive Art. 4, 7, 13, 15, 16, 17, 18, 19 …
- UAS UAS Regulation Art. 4, 6, 11, 13, 14, 15, 16, 17
- PPE PPE Regulation Art. 5, 8, 13, 15, 17, 18, 19
and 36 more in the regulation library · All regulation guides →
Problems people in this role ask about
Problem pages written for this role: 122 in all.
Questions about the role
A factory makes the product for us. Is the factory the manufacturer?
Not if the product is marketed under your name or trademark. The definition covers a person who has a product designed or manufactured and markets it under its own name (GPSR Article 3(8)).
We only put our logo on the box. Are we still the manufacturer?
The test is whether the product is placed on the market under your name or trademark (GPSR Article 13(1); Low Voltage Directive Article 10). The Commission's Blue Guide includes those who pack or label ready-made products under their own name. If the box presents the product as yours, assume you are the manufacturer.
Do the test reports have to be in our name?
No. The Blue Guide says the documentation and certificates need not be in the own-brand manufacturer's name, but it must be clear that they demonstrate compliance of the specific product placed on the market.
Can an authorised representative take over our duties?
Only the tasks named in a written mandate. Under the Low Voltage Directive the duty to design and manufacture in conformity and the duty to draw up the technical documentation cannot form part of the mandate (Article 7(1)), and the Blue Guide states that a manufacturer may in no circumstances discharge itself of its responsibilities to an authorised representative.
We are established outside the EU. Can we sell without an importer?
A product covered by the GPSR or by the CE acts listed in Article 4(5) of Regulation (EU) 2019/1020 may be placed on the market only when an economic operator established in the Union is responsible for it. Without an importer, the manufacturer can appoint an authorised representative with a written mandate.
Is the manufacturer liable for damage a product causes?
Liability for damage is a separate regime from the duties on this page. Under the Product Liability Directive (EU) 2024/2853, which applies to products placed on the market or put into service from 9 December 2026, the manufacturer of a defective product is liable for the damage it causes, as national law transposing the directive provides (Articles 2(1) and 8(1)(a)). Directive 85/374/EEC continues to apply to products placed on the market or put into service before that date (Article 21).
Sources
- Regulation (EU) 2023/988 on general product safety (consolidated text of 29 May 2026) EUR-Lex · accessed 5 October 2026
- Directive 2014/35/EU on electrical equipment (Low Voltage Directive), consolidated text of 30 May 2026 EUR-Lex · accessed 5 October 2026
- Regulation (EU) 2019/1020 on market surveillance and compliance of products (consolidated text of 12 August 2026) EUR-Lex · accessed 5 October 2026
- Decision No 768/2008/EC on a common framework for the marketing of products EUR-Lex · accessed 5 October 2026
- The 'Blue Guide' on the implementation of EU product rules 2022 (2022/C 247/01) European Commission, via EUR-Lex · accessed 5 October 2026
- Directive (EU) 2024/2853 on liability for defective products EUR-Lex · accessed 5 October 2026
About this page
- Reviewer
- Conphora compliance team
- Reviewed
- 5 October 2026
General information, not legal advice. Check the legal text or ask an adviser about your own product.
Conphora (2026). The manufacturer role in EU product compliance. Retrieved 13 October 2026 from https://www.conphora.com/roles/manufacturer/
Conphora (2026) The manufacturer role in EU product compliance. Available at: https://www.conphora.com/roles/manufacturer/ (Accessed 13 October 2026).
@misc{conphora2026themanufacturerroleineup,
author = {Conphora},
title = {The manufacturer role in EU product compliance},
year = {2026},
url = {https://www.conphora.com/roles/manufacturer/},
note = {Retrieved 13 October 2026}
} The other roles
See it working before you add a product
The Demo Company is a complete, read-only example — products, documents, supplier requests and deadlines. Open it with a free account; no card, no trial clock.
Free account · no card · opens in the Demo Company