CE marking from India: routes, documents and who is liable

Which products from India need CE marking, and which must never carry it?

CE marking exists only for products covered by EU harmonisation legislation that provides for it. The European Commission's CE-marking guidance is blunt on the flip side: affixing CE to any product outside that legislation is forbidden. So the first question is never "how do I get CE?" but "does any EU act require CE on my product at all?"

The harmonised families Indian exporters most often ship are toys, electricals and electronics, machinery and medical devices. Each has its own act, and a single product frequently falls under several at once. An LED lamp is caught by the Low Voltage Directive, the EMC Directive and RoHS simultaneously, carries one CE mark, and is backed by one combined compliance file.

For machinery, note the transition explicitly: Directive 2006/42/EC is current law today, and Regulation (EU) 2023/1230 replaces it from 14 January 2027. If you ship machinery, your 2027 shipments will be assessed under the Regulation, so plan the file against both.

Unharmonised consumer goods (the handicrafts, home textiles, jewellery and decor that dominate many Indian export catalogues) do not get CE marked. But they are not unregulated: since 13 December 2024 they are caught by the General Product Safety Regulation's Responsible Person requirement, covered in section 6 . For the India-side mirror of this scoping exercise (which products need BIS certification before they leave) see our BIS certification guide .

When can an Indian manufacturer self-declare CE, and when is a notified body mandatory?

Every CE act picks its conformity assessment procedures from a common menu of modules laid down in Decision No 768/2008/EC, Annex II. From Module A (internal production control, pure self-declaration) through Module B (EU-type examination by a notified body) up to Module H (full quality assurance). The critical point for an Indian exporter: you never choose the module freely . Each act fixes which modules are available for which products, and the same factory can be on a lawful self-declaration route for one product and a mandatory notified-body route for the next.

Self-declaration is real and lawful in four common cases. Toys can be self-declared under Module A where the applied harmonised EN 71 standards, published in the Official Journal, cover all relevant safety requirements (Directive 2009/48/EC, Article 19(2)). Low-voltage electrical equipment goes further: Module A is the only route, and no notified body even exists under the LVD (Directive 2014/35/EU, Annex III). EMC leaves the choice to the manufacturer between internal production control (Annex II) and EU-type examination (Annex III) under Directive 2014/30/EU, Article 14. And RoHS conformity is Module A under Directive 2011/65/EU, Article 7(b).

A notified body is mandatory in three common cases. Toys where EN 71 standards do not exist, were not or only partly applied, or were published with a restriction must go through EC-type examination (Module B) plus conformity to type (Module C) via a notified body (Directive 2009/48/EC, Articles 19(3) and 20). Machinery listed in Annex I Part A of Regulation (EU) 2023/1230 must use a notified-body route (Module B plus C, Module H or Module G (Articles 25 and 54, from 14 January 2027)) while Part B machinery may use Module A only if designed to harmonised standards or common specifications. And most medical devices involve a notified body: class III requires the full route of Annex IX (or Annex X plus XI) under Regulation (EU) 2017/745, Article 52, with only the lowest-risk devices escaping notified-body involvement.

Both failure modes cost real money. Exporters pay notified bodies for EC-type examinations on toys that EN 71 fully covers. Spending lakhs on a certificate the law never asked for. Others self-declare Annex I Part A machinery or a class III device. An unlawful placement that no test report can cure.

What is the EU Declaration of Conformity and who signs it?

The EU Declaration of Conformity (DoC) is the manufacturer's own legal statement that the product meets the applicable EU legislation. It is drawn up by the manufacturer (the Indian factory) not by a lab, not by the importer, and not by any certifier. The LVD's Module A text puts it plainly: the manufacturer ensures and declares conformity on its sole responsibility (Directive 2014/35/EU, Annex III). A test lab can never sign it for you, and a "CE certificate" sold by a consultancy is not a DoC.

Three mechanics matter in practice. First, one DoC can cover all the acts that apply to one product. The LED lamp's single declaration cites the LVD, EMC Directive and RoHS together. Second, the sequence is fixed: conformity assessment first, then the DoC, and only then is CE affixed (Directive 2009/48/EC, Article 4(2). (3)). A CE mark printed before the assessment is complete is a false claim. Third, retention: the manufacturer keeps the DoC for 10 years after the product is placed on the market, both for toys (Directive 2009/48/EC, Article 4(3)) and for RoHS-scope electricals (Directive 2011/65/EU, Article 7(c). (d)).

Distinguish the DoC sharply from a test report. The lab report is evidence that sits inside the technical file; the DoC is the legal declaration built on that evidence. Handing a buyer a stack of test reports without a signed DoC does not discharge anything. And handing over a DoC with no file behind it collapses at the first surveillance request.

What goes in the technical file and how long must you keep it?

The technical file (technical documentation) is the evidence pack behind the DoC. The material that lets a market surveillance authority reconstruct why you were entitled to declare conformity. The manufacturer draws it up and keeps it available. For toys it is drawn up per Article 21 and Annex IV of Directive 2009/48/EC and kept, together with the DoC, for 10 years after the product is placed on the market (Article 4(2). (3)). RoHS likewise requires technical documentation retained for 10 years (Directive 2011/65/EU, Article 7(b). (d)).

What the file must do, at minimum, is demonstrate that conformity assessment was carried out. Because that is exactly what your EU importer must verify before selling (Directive 2009/48/EC, Article 6(2)). Under the GPSR regime the EU Responsible Person must additionally be able to verify the documentation exists, provide it to authorities on request, and regularly check that the product still complies with it, keeping documented evidence of those checks (Regulation (EU) 2019/1020, Article 4(3)(a). (b); Regulation (EU) 2023/988, Article 16(2)).

The practical framing for an Indian exporter: the file lives with you in India, but three parties can demand it on short notice. Your importer, your EU authorised representative or Responsible Person, and any member-state surveillance authority. Keep it in English, keep it current against design and component changes, and keep it retrievable per model and batch, not as one undifferentiated folder. For how this pack sits alongside your Indian export paperwork, see our export documentation guide .

Who is liable in the EU when the manufacturer sits in India?

CE legislation distributes duties along a chain of economic operators, and where the manufacturer sits in India the in-EU links carry the enforceable weight. Walk the chain.

(1) The manufacturer in India. Conformity assessment, the technical file, the DoC, affixing CE and the 10-year retention duty never leave the factory. No importer, representative or certifier can perform them for you (Directive 2009/48/EC, Article 4; Directive 2011/65/EU, Article 7).

(2) The EU importer. When the manufacturer is outside the EU, the importer carries the in-EU compliance burden. It may place only compliant products on the market, must verify that the manufacturer carried out conformity assessment and drew up the technical documentation, must check the CE marking and required documents, and must add its own name and address to the product or its packaging or accompanying document (Directive 2009/48/EC, Article 6(1). (3), with equivalent importer articles in every CE directive).

(3) The authorised representative. An EU-established person mandated in writing by the manufacturer. Optional under most CE acts. But mandatory under the MDR: a device from a non-EU manufacturer may only be placed on the Union market if a sole authorised representative is designated, whose mandate is accepted in writing and who must verify the DoC and technical documentation and keep copies available (Regulation (EU) 2017/745, Article 11(1). (3)).

(4) The GPSR Responsible Person for consumer products. The newest link, covered in the next section.

This chain kills the most common myth in Indian CE conversations: "the factory self-certified, job done." Self-declaration modules are real, but the importer must still verify your assessment, check your documents and relabel with its own details. And a supplier who cannot hand over the file loses the account. Formally, legal exposure in the EU lands on the EU operators; commercially, the lost orders and delistings land squarely on the exporter.

How does the GPSR Responsible Person requirement change direct-to-consumer sales?

Since 13 December 2024 (Regulation (EU) 2023/988, Article 52), no consumer product may be placed on the EU market unless an economic operator established in the Union is responsible for the tasks of Article 4(3) of Regulation (EU) 2019/1020 (Regulation (EU) 2023/988, Article 16(1)). This catches CE-marked and unharmonised products alike. The toy and the cushion cover equally.

Four operators are eligible to be that Responsible Person (Regulation (EU) 2019/1020, Article 4(2)): an EU-established manufacturer; the importer, where the manufacturer is outside the EU; an authorised representative with a written mandate; or an EU fulfilment service provider where none of the first three exists.

The direct-to-consumer consequence is the one that catches Indian sellers: a courier or DDP parcel straight from Noida to a German consumer has no EU importer . With no appointed operator, the placing on the market is itself unlawful. Regardless of how complete the CE file is. The fix is a mandated EU authorised representative or a fulfilment provider, not ignoring the gap.

The labelling duty is dual and cumulative. The Responsible Person's name plus postal and electronic address must appear on the product, its packaging, the parcel or an accompanying document (Article 16(3)). and every online offer must show the manufacturer's details, the Responsible Person's details where the manufacturer is outside the EU, product identifiers with a picture, and warnings in the language of the member state of sale (Article 19(a). (d)). Satisfying one layer does not excuse the other.

Marketplaces are the enforcement arm: they must not list offers lacking the required traceability information and must execute dangerous-product removal orders within two working days (Article 22, with Recital 58 read with the Digital Services Act). That is the legal hook behind Amazon's Responsible Person field. The marketplace is not being cautious, it is complying. Penalties, by contrast, are national: Article 44 delegates them to member states, so there is no single EU-wide fine figure to quote. The certain, immediate penalty is delisting.

Which CE marking mistakes cost Indian exporters their EU orders and accounts?

Eight failure patterns come up again and again. Each pairs a wrong belief with the rule that defeats it and the commercial bill that follows.

1. 1 "Self-certified, done" Self-declaration is a conformity route, not the end of the chain. The importer must still verify your assessment and documents and relabel with its own details (Dir 2009/48/EC Art 6 and equivalents). No handover pack means no lawful sale. And a lost account.
2. 2 Wrong module, in either direction Paying a notified body for a toy fully covered by OJ-cited EN 71 is wasted money (Module A was lawful, Dir 2009/48/EC Art 19(2)). Self-declaring Annex I Part A machinery under Reg (EU) 2023/1230 or a class III medical device is an unlawful placement no invoice can fix.
3. 3 CE on out-of-scope products Affixing CE to products outside CE legislation is forbidden outright (Commission CE-marking guidance). Handicrafts and home textiles get a GPSR Responsible Person, not a CE mark.
4. 4 Missing the dual RP address duty The Responsible Person's postal and electronic address must appear on the product or parcel and in every online listing (Reg (EU) 2023/988 Arts 16(3), 19). Printing it on the box while the listing stays blank still fails. And the marketplace gate catches exactly that.
5. 5 Confusing the REACH Only Representative with the GPSR RP or CE authorised representative An OR mandate under Reg (EC) No 1907/2006 Art 8 covers chemical registration only. It satisfies neither GPSR Article 16 nor any CE authorised-representative requirement unless the same entity is separately mandated for those roles.
6. 6 Quoting one EU-wide penalty figure GPSR Article 44 delegates penalties to member states, so any single "EU fine" number is invented. The reliable, uniform sanction is marketplace removal within two working days of an order (Art 22(4)).
7. 7 Forgetting the MDR is stricter For medical devices the authorised representative is not optional. A sole, written-mandate representative is a condition of market access for any non-EU manufacturer (Reg (EU) 2017/745 Art 11(1)). No representative, no placement.
8. 8 Ignoring the 2027 machinery switch Machinery exporters must plan for 14 January 2027, when Regulation (EU) 2023/1230 replaces Directive 2006/42/EC. And re-check which Annex I part the product falls in, because Part A means a mandatory notified body.

What is the CE marking checklist before your first EU shipment?

Run this in order. Each step depends on the one before it.

1. 1 Scope List every EU act your product falls under. Toys / LVD / EMC / RoHS / machinery / MDR, often several at once. Confirm CE is provided for; if the product is unharmonised, route to GPSR-only compliance instead.
2. 2 Route Read the conformity-assessment article of each act and fix the module. Module A self-declaration where allowed, notified body where mandated. For toys, check the current OJ citation status of the EN 71 parts you rely on.
3. 3 Test Obtain test reports against the harmonised standards you applied. These are the evidence inside the file, not the declaration itself.
4. 4 Technical file Compile per the act (toys: Art 21/Annex IV of Dir 2009/48/EC), in English, retrievable per model. Plan 10-year retention.
5. 5 DoC Draw up and sign the EU Declaration of Conformity covering all applicable acts, on the manufacturer's sole responsibility. 10-year retention alongside the file.
6. 6 Mark Affix CE to the product. Plus the importer's details and, for consumer goods, the Responsible Person's details on product, packaging or parcel.
7. 7 Appoint Confirm who your EU operator is. The importer for B2B, or a written-mandate authorised representative or fulfilment provider for D2C under GPSR Art 16. Medical devices: a sole authorised representative before any placement.
8. 8 Listings Every online offer shows the manufacturer's and Responsible Person's names with postal and electronic addresses, product identifiers with a picture, and warnings in the buyer's language (GPSR Art 19).
9. 9 Handover pack for the importer DoC + technical-file access + labelling proofs, so the importer's Article 6-type verification passes on the first shipment.
10. 10 Diary 14 January 2027: the Machinery Regulation switch, if you ship machinery. Re-check the Annex I classification before your first 2027 shipment.

Match the product against the harmonised families. Toys (Dir 2009/48/EC), low-voltage electricals (Dir 2014/35/EU), EMC (Dir 2014/30/EU), RoHS scope (Dir 2011/65/EU), machinery (Reg 2023/1230 from 14 Jan 2027), medical devices (Reg 2017/745). If none apply, CE is forbidden on the product. But GPSR still applies to any consumer product. </>), soThat: (<> You neither skip a mandatory CE mark nor unlawfully affix CE to an out-of-scope product, and you know whether your path is CE-plus-GPSR or GPSR-only. </>), }, , , , , ]} conclusion= />

Brightline Electricals in Noida makes 230V LED desk lamps and wants two EU channels in 2026: pallets to a German distributor (B2B) and direct sales on Amazon.de fulfilled from India (D2C). It has no EU entity. </> } result= >

Frequently asked questions

Can an Indian manufacturer self-certify CE marking without any EU testing body?

Yes, where the applicable act fixes Module A as the route. For low-voltage electricals, Module A is the only route and no notified body even exists under the LVD (Dir 2014/35/EU, Annex III). EMC offers the manufacturer a choice (Dir 2014/30/EU, Art 14), RoHS is Module A (Dir 2011/65/EU, Art 7(b)), and toys can be self-declared where OJ-cited EN 71 standards cover all relevant safety requirements (Dir 2009/48/EC, Art 19(2)). But toys without full EN 71 coverage, Annex I Part A machinery under Reg (EU) 2023/1230 and class III medical devices always require a notified body.

Do handicrafts, home textiles or jewellery exported from India need CE marking?

No. And they must not carry it. CE may only be affixed to products covered by legislation providing for it; anything else is forbidden. Unharmonised consumer goods are instead caught by the GPSR: since 13 December 2024 they need an EU-established Responsible Person (Reg (EU) 2023/988, Art 16(1)), with contact details on the parcel and in every listing.

Who has to keep the Declaration of Conformity and technical file, and for how long?

The Indian manufacturer draws up both on its sole responsibility and keeps them for 10 years after placing the product on the market (Dir 2009/48/EC Art 4(3); Dir 2011/65/EU Art 7(c). (d)). The EU importer must verify they exist before selling, and a GPSR Responsible Person must be able to produce the documentation for authorities and run documented regular compliance checks.

What is the difference between a CE authorised representative, a GPSR Responsible Person and a REACH Only Representative?

Three legally distinct EU-address roles, each needing its own mandate. The CE authorised representative acts under the CE acts (mandatory and sole under the MDR, Reg (EU) 2017/745 Art 11); the GPSR Responsible Person is required for every consumer product since 13 December 2024 (Reg (EU) 2023/988 Art 16); the REACH Only Representative covers chemical registration only (Reg (EC) No 1907/2006, Art 8). One entity can hold all three, but holding one never satisfies the others.

Can I ship CE-marked products directly to EU consumers by courier without an EU importer?

Not without appointing an EU operator. A courier parcel straight from India has no EU importer, so GPSR Art 16(1) makes the placing on the market itself unlawful since 13 December 2024, however complete the CE file. The fix is a written-mandate authorised representative or an EU fulfilment provider, with the RP's postal and electronic address on the parcel and in every listing.

Sources & citations

• [European Commission. CE marking (Single Market)](https://single-market-economy.ec.europa.eu/single-market/ce-marking_en).
• [Directive 2009/48/EC on the safety of toys](https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32009L0048).
• [Directive 2014/35/EU (Low Voltage Directive)](https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32014L0035).
• [Directive 2014/30/EU (EMC Directive)](https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32014L0030).
• [Directive 2011/65/EU (RoHS)](https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32011L0065).
• [Regulation (EU) 2023/1230 on machinery](https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32023R1230).
• [Decision No 768/2008/EC (conformity assessment modules)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32008D0768).
• [Regulation (EU) 2017/745 (Medical Device Regulation)](https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32017R0745).
• [Regulation (EU) 2020/561 (MDR date of application amendment)](https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32020R0561).
• [Regulation (EU) 2023/988 (General Product Safety Regulation)](https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32023R0988).
• [Regulation (EU) 2019/1020 on market surveillance](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32019R1020).
• [Regulation (EC) No 1907/2006 (REACH, consolidated)](https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:02006R1907-20260511).

Update history

• 2026-08-18 First published.