Who is an importer under the CRA?
Depends on your role
Depends on your role. An importer places on the EU market a product with digital elements from a manufacturer established outside the EU, and must place only compliant products on the market, verifying the conformity assessment, documentation, CE marking and manufacturer identification [[F-012]].
The deciding factors
| Factor | If true | If false | Source |
|---|---|---|---|
| You bring a non-EU manufacturer's product onto the EU market | Importer obligations | Not an importer | F-012 |
| You sell it under your own name or brand | You are the manufacturer | Importer or distributor obligations instead | F-106 |
| The manufacturer has an authorised representative in the EU | Representative holds the documents; importer still verifies | Importer verifies directly with the manufacturer | F-034 |
| Has a direct or indirect connection to a device or network | It is a product with digital elements | Likely out of scope | F-005 |
Check your own product
Start the short scope check. Every legally material fact — EU availability, commercial activity, exclusions, your role — is asked, never assumed.
Example scenarios
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EU distributor buying devices from a Japanese maker and selling them in the EU
In scope — operator obligations differ by role · role: _
First placing a non-EU product on the EU market: the product is in scope and the business holds importer obligations.
Deciding fact: Art. 3(1), Art. 2(1)
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Same business, now selling the devices under its own brand
Likely in scope · role: _
Rebranding makes it the manufacturer; the importer role falls away.
Deciding fact: Art. 3(1), Art. 2(1)
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EU reseller buying from an EU-established manufacturer
In scope — operator obligations differ by role · role: _
No import from outside the EU takes place, so the reseller is a distributor.
Deciding fact: Art. 3(1), Art. 2(1)
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Importer of a device that is a medical device
Likely out of scope · role: _
Medical devices are excluded from this Regulation, so importer obligations under it do not arise.
Deciding fact: Art. 2(2)–(4), (6)–(7)
Each scenario is a fixture: the shared CEMarque rules engine evaluates its inputs at build time and the page cannot be served if the outcome shown here differs from the engine's.
Edge cases
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Why
Who is an importer
The importer is the business that places a product with digital elements from a manufacturer established outside the EU on the EU market. Importers place only compliant products on the market; they verify that the manufacturer has carried out the conformity assessment and drawn up the technical documentation, that the product bears the CE marking, and that the manufacturer is identified [1]. They also indicate their own name and address, report known vulnerabilities to the manufacturer, keep the declaration of conformity and cooperate with authorities [1]. These obligations apply with the rest of the Regulation from 11 December 2027 [2].
Verify, not redo
The importer's obligations are about verification and diligence, not about re-doing the manufacturer's assessment [1]. Where the manufacturer has appointed an authorised representative, that representative keeps the declaration and technical documentation available; the importer's verification duty remains [3].
When an importer becomes a manufacturer
Marketing the product under your own name or trademark makes you the manufacturer, with the full obligation set, even if the non-EU company developed it [4] [5]. Importers who rebrand should run the check as manufacturers.
Applicability first
The product must be in scope for any of this to matter [6]. The scope check reports the apparent role from your answers; the full check on CEMarque lists the obligations for it.
What to do next
CRARequired only answers applicability. CEMarque carries your answers forward and adds your role, class, conformity route, dates, obligations, and a permanent cited verdict.
Check my product Run the full cited determination on CEMarque
Related applicability questions
Sources
- F-012 Importers place only compliant products on the market; verify conformity assessment, technical documentation, CE marking and manufacturer identification; indicate their own name and address; report known vulnerabilities to the manufacturer; keep the declaration of conformity; cooperate with authorities. Art. 19 EUR-Lex ↩
- F-003 The Regulation applies in full from 11 December 2027. Art. 71(2) EUR-Lex ↩
- F-034 A manufacturer may appoint an authorised representative by written mandate; the representative keeps the declaration of conformity and technical documentation at the disposal of authorities and cooperates with them. Non-EU manufacturers: reporting is routed via the representative's Member State. Art. 18, Art. 3(15), Art. 14(7) EUR-Lex ↩
- F-106 Marketing a product under your own name or trademark makes you the manufacturer even if someone else developed it. Art. 3(13), Art. 21 EUR-Lex ↩
- F-011 Manufacturer: a natural or legal person who develops or manufactures products with digital elements or has them designed, developed or manufactured, and markets them under their name or trademark, whether for payment, monetisation or free of charge. Art. 3(13) EUR-Lex ↩
- F-005 A product with digital elements is a software or hardware product and its remote data processing solutions, including components placed on the market separately, whose intended purpose or reasonably foreseeable use includes a direct or indirect logical or physical data connection to a device or network. Art. 3(1), Art. 2(1) EUR-Lex ↩
- F-010 Excluded: medical devices (Regulation (EU) 2017/745) and in vitro diagnostics (2017/746) and motor-vehicle type-approved products (2019/2144) (Art. 2(2)); civil aviation products certified under Regulation (EU) 2018/1139 (Art. 2(3)); marine equipment under Directive 2014/90/EU (Art. 2(4)); spare parts made to identical specifications (Art. 2(6)); products developed or modified exclusively for national security or defence, or designed exclusively to process classified information (Art. 2(7)). Art. 2(2)–(4), (6)–(7) EUR-Lex ↩
CRARequired answers applicability only, using scope logic and cited regulatory facts maintained by CEMarque, which encodes Regulation (EU) 2024/2847 and published guidance as of Facts v2026.09.4 (10 September 2026). Results are "likely" or "conditional" readings of your answers, not a legal opinion and not a conformity assessment. Run the full cited determination on CEMarque before you act. Methodology.