CE Marking Guide for Importers

If you import consumer goods from China into the European Union, a buyer, a retailer merchandising team or an Amazon EU compliance request will sooner or later ask you to confirm CE Marking compliance, with technical documentation and a signed EU Declaration of Conformity. This guide explains the CE mark meaning in practical terms: which EU directives apply, how conformity assessment works, when a Notified Body is required, and how to verify everything at the Chinese factory before the container leaves Shenzhen, Ningbo, Shanghai or Qingdao.

What Is CE Marking? (Meaning, Legal Basis, and Why It Exists)

CE Marking is a European Union conformity mark that a manufacturer or importer affixes to certain products to declare that the product meets the essential health, safety and environmental protection requirements of the applicable EU harmonisation legislation at the moment it was placed on the EU market. The letters CE stand for Conformité Européenne (European Conformity in French), a designation confirmed by the European Commission in a 2014 press release.

CE Marking at a glance:

Aspect	What it means for the importer
Legal foundation	Council Directive 93/68/EEC of 22 July 1993, modernised in 2008 by the New Legislative Framework (Regulation (EC) 765/2008, Decision 768/2008/EC)
Scope	More than 25 pieces of EU harmonisation legislation: toys, electrical and electronic equipment, machinery, pressure equipment, PPE, medical devices, construction products and more
Territory	32 countries (27 EU member states plus Iceland, Norway, Liechtenstein), recognition in Turkey and Switzerland, mandatory in Northern Ireland
Retention	Technical documentation and Declaration of Conformity kept at least 10 years after the last unit is placed on the market
Mark design	Minimum 5 mm vertical height, proportions preserved

CE Marking is not a quality mark, not a certification mark, and not an approval issued by an EU authority: it is a declaration by the manufacturer (assisted by a Notified Body for higher-risk products) that the product meets the essential requirements. "CE approved" has no legal meaning, and "CE certified" is improper unless a Notified Body issued an EU-type examination certificate; the correct term is "CE marked".

The cardinal principle is free circulation: a CE marked product sells across the EU Single Market without country-by-country re-certification. The mark coexists with other labels (WEEE crossed-out bin symbol, energy label) without replacing them.

The New Legislative Framework: Regulation 765/2008 and Decision 768/2008

The New Legislative Framework (NLF), adopted in 2008, modernised the CE Marking system with two complementary EU instruments. Regulation (EC) 765/2008 governs accreditation and market surveillance of products, and Decision 768/2008/EC provides the common reference framework of conformity assessment modules that individual sectoral directives incorporate.

The earlier "New Approach" of 1985 had laid down the core principles: essential requirements, harmonised standards, conformity assessment, CE marking. The NLF clarified what matters to an importer: obligations distributed along the supply chain (manufacturer, authorised representative, importer, distributor); Notified Bodies accredited and listed in the NANDO database; standardised modules from A (internal production control) to H (full quality assurance); and market surveillance across all member states.

The Commission's "Blue Guide" (2000, updated 28 February 2014 and 26 July 2016) remains the operational reference. Since 16 July 2021, the Market Surveillance Regulation (EU) 2019/1020 requires an economic operator established in the EU to keep the technical documentation and Declaration of Conformity available to authorities. Full texts sit on EUR-Lex.

Which EU Directives and Regulations Require CE Marking (More Than 25 Product Groups)

CE Marking is required only for products covered by specific EU harmonisation legislation that mandates it. More than 25 product groups fall within scope, and identifying which directive or regulation applies to your product is the first step of any CE Marking process.

The main families relevant to consumer goods importers:

Product family	Applicable EU legislation
Consumer products	Toy Safety Directive 2009/48/EC, replaced by Regulation (EU) 2025/2509 applicable from 2028; General Product Safety Regulation (EU) 2023/988 for non-CE-marked consumer products.
Electrical and electronic equipment	Low Voltage Directive 2014/35/EU, EMC Directive 2014/30/EU, Radio Equipment Directive 2014/53/EU, RoHS Directive 2011/65/EU, WEEE Directive 2012/19/EU, Eco-design Directive 2009/125/EC.
Machinery and equipment	Machinery Directive 2006/42/EC, replaced by Regulation (EU) 2023/1230 applicable from 20 January 2027; Pressure Equipment Directive 2014/68/EU; Simple Pressure Vessels Directive 2014/29/EU; Lifts Directive 2014/33/EU; Cableway Regulation (EU) 2016/424; ATEX Directive 2014/34/EU; Gas Appliances Regulation (EU) 2016/426.
Personal safety	Personal Protective Equipment Regulation (EU) 2016/425.
Measuring and weighing	Non-Automatic Weighing Instruments Directive 2014/31/EU, Measuring Instruments Directive 2014/32/EU.
Medical	Medical Devices Regulation (EU) 2017/745 (since 26 May 2021), In Vitro Diagnostic Regulation (EU) 2017/746 (since 26 May 2022).
Construction and infrastructure	Construction Products Regulation (EU) 305/2011, revised by (EU) 2024/3110; Recreational Craft Directive 2013/53/EU.
Energy and environment	Fertilizing Products Regulation (EU) 2019/1009, Batteries Regulation (EU) 2023/1542.
Dangerous goods	Pyrotechnic Articles Directive 2013/29/EU, Explosives for Civil Uses Directive 2014/28/EU.

CE marking toys is a frequent importer case: Regulation (EU) 2025/2509 tightens chemical and digital safety, as detailed in our EU Toy Safety Regulation 2025/2509 guide.

Three cross-cutting frameworks complete the picture: REACH Regulation (EC) 1907/2006 for chemical substances in the product, the PPWR (Regulation (EU) 2025/40) for packaging since 12 February 2025, and the Cosmetics Regulation (EC) 1223/2009 for cosmetics, which are not CE marked.

Outside scope: food, feed, medicinal products, standalone REACH chemicals and general consumer textiles (unless they qualify as PPE). CE marking applies across the 30 EEA countries, is recognised in Turkey and Switzerland under mutual recognition arrangements, and remains mandatory in Northern Ireland.

Product-Specific Coverage: Toys, Electronics, Machinery, PPE, Medical Devices, Construction Products, Cosmetic Packaging

For most consumer goods imported from China, more than one CE Marking directive applies simultaneously: a wireless electronic toy may fall under the Toy Safety Regulation (EU) 2025/2509, the Radio Equipment Directive 2014/53/EU, RoHS Directive 2011/65/EU, WEEE Directive 2012/19/EU and REACH in parallel.

Toys. Regulation (EU) 2025/2509 replaces Directive 2009/48/EC from 2028. Conformity assessment uses Module A (internal production control) or Module B (EU-type examination) plus Module C, with Notified Body assessment recommended for complex toys. Details in our EU Toy Safety Regulation 2025/2509 guide.

Electrical and electronic equipment. The Low Voltage Directive 2014/35/EU allows Module A self-declaration for equipment rated 50 V to 1000 V AC or 75 V to 1500 V DC. The Radio Equipment Directive 2014/53/EU may require a Notified Body for non-harmonised frequency bands; the EMC Directive 2014/30/EU, RoHS Directive 2011/65/EU and WEEE Directive 2012/19/EU apply in parallel.

Machinery. Regulation (EU) 2023/1230, applicable from 20 January 2027, replaces Directive 2006/42/EC. Non-Annex IV machinery follows Module A self-declaration; higher-risk Annex IV items require Module B + C or Module H with a Notified Body.

Personal protective equipment. Regulation (EU) 2016/425 defines three risk categories: Category I allows Module A self-declaration, Category II requires EU-type examination (Module B) by a Notified Body, Category III (mortal risks) adds Module C2 or Module D.

Medical devices. Regulations (EU) 2017/745 and (EU) 2017/746 (in vitro diagnostics) classify devices from Class I to Class III. Class I can be self-declared; Classes IIa, IIb and III require Notified Body involvement under a quality management system.

Construction products. Regulation (EU) 305/2011, revised by (EU) 2024/3110, requires a Declaration of Performance rather than a standard Declaration of Conformity, based on harmonised European standards or European Assessment Documents under the AVCP system.

Cosmetic packaging. Cosmetics are not CE marked: the Cosmetics Regulation (EC) 1223/2009 requires an EU responsible person, CPNP notification, a Product Information File and ISO 22716 GMP manufacturing (see our ISO 22716 GMP cosmetics guide). Their packaging falls under the PPWR since 12 February 2025 (see our PPWR packaging regulation guide).

Any CE marked product containing chemical substances is also subject to REACH, in particular Annex XVII restrictions and SVHC (Substances of Very High Concern) disclosure under Article 33; our REACH compliance guide covers the chemistry obligations in depth.

Self-Declaration vs Notified Body: The Modules A to H of Conformity Assessment

The conformity assessment procedure depends on the product's risk level, as defined in the applicable EU harmonisation legislation. Decision 768/2008/EC introduced eight primary modules (A to H), with variants (A1, A2, C1, C2, D1, E1, F1, H1), combining internal production control, EU-type examination by a Notified Body, quality management system audits and unit verification.

Module	Name	Manufacturer role	Notified Body role	Typical use case
A	Internal production control	Self-declares, compiles technical documentation	None	Low-risk: LVD, EMC, Category I PPE
A1	A + supervised product testing	Self-declares plus testing	Supervised product testing only	Some LVD or EMC scenarios
A2	A + supervised checks	Self-declares plus random checks	Random product checks at intervals	Some low-risk products
B	EU-type examination	Provides type sample and technical documentation	Examines sample, issues EU-type examination certificate	Higher-risk products, first step before C, D, E or F
C	Conformity to type	Builds to certified type	None (unless C1 or C2)	Follows Module B
C1	C + supervised testing	Builds to type plus supervised testing	Product testing	Higher-risk products
C2	C + random checks	Builds to type plus random checks	Random product checks	Category III PPE
D	Production quality assurance	Runs approved production QMS	Approves and audits the QMS	Follows B; Category III PPE alternative
D1	Production QA (without B)	Runs approved production QMS	Approves and audits the QMS	Some machinery scenarios
E	Product quality assurance	Runs approved final-inspection QMS	Approves and audits the QMS	Follows Module B, some machinery
E1	Final inspection QA (without B)	Runs approved final-inspection QMS	Approves and audits the QMS	Some scenarios
F	Product verification	Presents units against certified type	Verifies each unit or statistical sample	Follows Module B, low-volume higher-risk
F1	Product verification (without B)	Presents each unit for verification	Verifies each unit	Some scenarios
G	Unit verification	Presents each individual unit	Examines and tests every unit	One-off or custom products
H	Full quality assurance	Runs approved design and production QMS	Approves and audits design and production QMS	Class III medical devices, complex machinery
H1	H + design examination	Runs QMS and presents design	Approves QMS and examines design	Highest-risk devices

The decision logic for the importer:

1. Identify which modules the applicable directive allows for your product category.
2. If Module A is permitted, the manufacturer self-declares: technical documentation and Declaration of Conformity suffice, no Notified Body.
3. If Module B plus C, D, E or F, or Module G or H, is required, a Notified Body listed in NANDO must intervene, and its four-digit number appears next to the CE mark.
4. Verify the manufacturer has identified the module matching the product's risk classification.

Only the procedures defined in the applicable EU legislation are valid: some organisations sell "voluntary CE certificates" with no legal recognition, against which the European Commission explicitly warns. Genuine compliance is demonstrated by testing against the applicable harmonised standards (specifications adopted by CEN, CENELEC or ETSI, published in the Official Journal of the EU), where a CE compliance testing service coordinated before shipment creates its value.

NANDO: The EC Database for Notified Body Selection

NANDO (New Approach Notified and Designated Organisations) is the European Commission public database listing all Notified Bodies authorised to perform third-party conformity assessment under specific EU harmonisation legislation. It is the authoritative source to verify the identity, scope and validity of any Notified Body a Chinese supplier claims to have used.

For each body, NANDO records name and country, the four-digit identification number, the directives covered, the modules it may perform and the effective dates. Access is public at webgate.ec.europa.eu/single-market-compliance-space/notified-bodies.

To verify a supplier's Notified Body claim:

1. Ask the manufacturer for the four-digit number affixed next to the CE mark.
2. Search NANDO by that number.
3. Check the body name matches the Declaration of Conformity and the EU-type examination certificate.
4. Check authorisation for the specific directive or regulation.
5. Check the authorisation covers the module claimed.
6. Check the authorisation is active, not suspended or withdrawn.

If the number is absent from NANDO, or the scope does not match, you face a critical red flag. Fraud scenarios detected in factory audits include an invented number, a body not authorised for the directive claimed, a withdrawn authorisation, or a number valid for a different module. AQF coordinates verification with a Notified Body listed in the EC NANDO database and partner laboratories through our lab testing services hub.

Technical Documentation: What to Compile and How to Retain It for 10 Years

Technical documentation is the manufacturer's compiled evidence that the product meets the essential requirements of the applicable EU harmonisation legislation. It must be compiled before the product is placed on the EU market, kept up to date, and retained by the manufacturer, authorised representative or importer for at least 10 years after the last unit is placed on the market.

A complete file typically contains:

1. General description of the product, intended use, variants, identification.
2. Design and manufacturing drawings and schemes (components, sub-assemblies, circuits).
3. Risk assessment identifying each applicable essential requirement and how it is addressed.
4. List of harmonised standards or other technical specifications used, as referenced in the Official Journal of the EU.
5. Test reports from ISO/IEC 17025-accredited laboratories demonstrating compliance.
6. Manufacturing quality control procedures, including in-process inspections and final testing.
7. Where a Notified Body is involved, EU-type examination certificate, QMS audit certificates, product verification certificates.
8. The signed EU Declaration of Conformity.
9. User instructions and safety information in the language(s) of the destination member states.
10. Packaging and marking artwork, including CE mark placement.

Keep the file at least 10 years after the last unit is placed on the market, in paper or electronic form, in general within the EEA, and provide it to any competent national market surveillance authority on request. Chemistry evidence is a frequent weak point: restricted-substance reports must reference the correct standard editions, which a chemistry screening service verifies, with broader context in our REACH compliance guide. Amazon EU sellers should note the Compliance Portal routinely requires uploaded extracts (Declaration of Conformity plus test report summaries) for regulated categories, on pain of listing suspension.

EU Declaration of Conformity: What the Signed Statement Must Contain

The EU Declaration of Conformity is a signed statement by the manufacturer or authorised representative attesting that the product meets all applicable EU harmonisation legislation. It is mandatory, must accompany or be available with the product, and must be retained with the technical documentation for at least 10 years after the last unit is placed on the market.

The declaration must contain:

1. Unique product identification (name, model, batch or serial number).
2. Name and address of the manufacturer, and of the authorised representative where applicable.
3. A statement that the declaration is issued under the sole responsibility of the manufacturer.
4. The object of the declaration, with photographs where relevant.
5. References to the applicable EU harmonisation legislation, by number.
6. References to the harmonised standards used, with edition year, or other technical specifications.
7. Where a Notified Body was involved, its name, four-digit number, description of its intervention and certificate reference.
8. Additional information required by specific legislation (for construction products, Declaration of Performance detail).
9. Place and date of issue, name, function and signature of the empowered signatory.

The declaration must be translated into the language(s) required by the destination member states. Errors detected in factory audits include signature by a fictional or non-manufacturer entity, a missing Notified Body number when Module B, C1, C2, D, E, F, G or H was applied, references to standards withdrawn from the Official Journal, product identification that does not match the goods shipped, a signature dated after shipment, and missing translations. For Amazon EU sellers, this declaration is among the most frequently requested PDF uploads in the Compliance Portal; it must be signed, dated and accurate.

Factory-Side Documentation Workflow at Your Chinese Supplier

The gap between CE Marking on paper and CE Marking in the container is a factory-side documentation workflow. Whether you source directly from a Chinese manufacturer or through a trading company, the compliance evidence must be verified at the source before the shipment leaves the port.

A robust workflow follows five steps:

1. Vet the manufacturer for CE Marking capacity. Identify the actual manufacturer, not just the trading company, and confirm it knows which EU directives apply to the product. A common trap: a CE certificate obtained by another factory for a different model.
2. Review the technical documentation at the factory. Verify all ten components above are present, with test reports from ISO/IEC 17025-accredited laboratories referencing the correct standard editions; a chemistry screening service covers the restricted-substance evidence.
3. Verify the Notified Body, where applicable. For Module B, C, D, E, F, G or H, cross-check the four-digit number against NANDO and confirm the certificate is valid and matches the product model.
4. Verify the CE mark physically on the production line. Both letters same vertical dimension, minimum 5 mm, proportions preserved, visible, legible, indelible; placed on the product by preference, otherwise on packaging or accompanying documents, with the Notified Body number where required. This verification belongs to a first article inspection guide before mass production and a pre-shipment inspection guide before loading, delivered on the ground through a pre-shipment inspection service.
5. Document the chain of custody from manufacturer to importer. Every unit CE marked, the Declaration of Conformity available, the technical documentation location and 10-year retention arrangement confirmed. Our factory audit in China guide describes the full review, delivered through our factory audit service.

Red flags to detect at the factory:

Red flag	What the inspector checks
CE mark with no conformity assessment ever performed	No test reports, no risk assessment, no Declaration of Conformity on file
Technical documentation missing, forged or reused	File contents match the actual product model and standard editions
Declaration of Conformity signed by a fictional entity	Signatory identity and manufacturer name verified
Forged or non-accredited test reports	Issuing laboratory holds ISO/IEC 17025 accreditation
Withdrawn or wrong-edition standards	Standards referenced match the current Official Journal listings
Non-compliant CE mark dimensions	5 mm minimum height, proportions preserved, legible and indelible
Mixed compliant and non-compliant units in one container	Sampling across cartons, not only top layers

Separately, product packaging must satisfy the PPWR, covered in our PPWR packaging regulation guide.

AQF Coordination: Lab Testing and Inspection Along the CE Marking Path

AQF coordinates the CE Marking compliance path for EU importers sourcing consumer goods in China across three touchpoints: lab testing at partner ISO/IEC 17025-accredited laboratories for the essential requirements, factory audits at the Chinese manufacturer for documentation and QMS verification, and pre-shipment inspections at the finished goods line for CE mark on-product verification and packaging documentation checks.

Lab testing coordination. AQF coordinates testing against the applicable harmonised standards with partner ISO/IEC 17025-accredited laboratories: EN 71 (toys), EN 60335 (household appliances), EN 62368 (audio-video and IT equipment), EN 55032 (EMC), EN 71-3 (migration of certain elements), EN 14682 (cords and drawstrings), EN 12472 (nickel release). AQF operates as an ISO/IEC 17020-accredited inspection body and coordinates with a Notified Body listed in the EC NANDO database when third-party assessment is required. Our CE compliance testing service structures this coordination.

Factory audit at the Chinese manufacturer. The audit covers technical documentation review, QMS assessment (decisive under Module D, E or H), Notified Body certificate verification, harmonised standards evidence and CE mark artwork verification.

Pre-shipment inspection at the finished goods line. The inspector verifies the CE mark on product and packaging (dimensions, placement, legibility), Declaration of Conformity availability and related labelling: PPWR conformity, energy label, WEEE crossed-out bin symbol, battery marking under the Batteries Regulation (EU) 2023/1542. Our pre-shipment inspection guide details the checklist logic.

The Amazon EU seller angle. Amazon EU marketplaces require uploaded Declarations of Conformity and test reports for regulated categories (electronics, toys, PPE, cosmetic packaging) via the Compliance Portal; failing to respond exposes the listing to suspension. The third-party seller is often the importer of record, legally responsible for CE Marking and for keeping documentation available for 10 years. AQF supports sellers with a pre-shipment documentation package, as outlined in our Amazon FBA requirements guide.

The practical takeaway: CE Marking compliance is not a single event but a chain, from supplier vetting through pre-shipment inspection; AQF integrates these touchpoints so the importer receives a documented compliance package before the container ships.

CE Marking vs UKCA: The Post-Brexit Position and 1 August 2023 Update

The United Kingdom left the EU on 31 January 2020, and the transition period ended on 31 December 2020. The UK introduced its own conformity mark, UKCA (UK Conformity Assessed), but on 1 August 2023 the UK government announced the indefinite recognition of CE marking for most product categories placed on the Great Britain (England, Scotland, Wales) market.

The current position, subject to re-verification on gov.uk at publication:

• Great Britain: CE marking is indefinitely recognised for most product categories, per the 1 August 2023 Department for Business and Trade announcement; UKCA remains available but not mandatory. A limited set follows separate regimes: medical devices, construction products, rail products, marine equipment, unmanned aircraft and transportable pressure equipment.
• Northern Ireland: under the Windsor Framework (applicable since 24 January 2024, updating the Northern Ireland Protocol), the region stays aligned with the EU Single Market for goods: CE marking is mandatory, UKCA is not required, and the UKNI marking may accompany the CE mark for goods assessed by a UK body.

Market	CE marking	UKCA marking
EU and EEA (30 countries)	Mandatory for products in scope	Not applicable
Turkey and Switzerland	Recognised under mutual recognition arrangements	Not applicable
Great Britain (England, Scotland, Wales)	Indefinitely recognised since 1 August 2023 for most categories	Available as an alternative, not mandatory
Northern Ireland	Mandatory under the Windsor Framework	Not required; UKNI may accompany CE for UK-assessed goods

For a Chinese manufacturer supplying an EU plus UK importer, CE marking satisfies both markets simultaneously for most categories, with no dual CE + UKCA marking needed; for the exceptions above, verify the separate UK regime and add UKCA where required.

Other markets run their own frameworks, and CE Marking has no legal effect outside its territory: the US relies on separate regimes (FCC for radio equipment, FDA for medical devices, CPSIA for children's products, covered in our CPSIA compliance guide, and MoCRA for cosmetics, covered in our MoCRA cosmetics guide); China domestic sales may require CCC; Japan applies the PSE mark; Australia and New Zealand use the RCM; the Gulf states apply the G-mark for certain categories.

Key Takeaways for Importers

• CE Marking is a manufacturer declaration, not a certification: no EU authority "approves" the product, and the legal responsibility sits with the manufacturer and the EU importer of record.
• More than 25 pieces of EU legislation trigger CE Marking; most consumer electronics, toys and PPE cumulate several at once.
• Self-declaration (Module A) suffices for low-risk products; higher-risk categories require a Notified Body whose four-digit number must be verifiable in NANDO.
• Technical documentation and the Declaration of Conformity must exist before shipment and be retained for 10 years.
• The decisive moment is before the container leaves China: factory-side verification of the mark, the documents and the Notified Body claim is what protects the importer from customs refusal, Safety Gate alerts, recalls and Amazon EU listing suspensions.

Frequently Asked Questions

What is CE Marking?

CE Marking is a European Union conformity mark that a manufacturer or importer affixes to certain products to declare that the product meets the essential health, safety and environmental protection requirements of the applicable EU harmonisation legislation. CE stands for Conformité Européenne (European Conformity in French), a designation confirmed by the European Commission in a 2014 press release. The mark allows free sale across the European Economic Area, Turkey, Switzerland and Northern Ireland.

What does CE mean on a product?

CE means the manufacturer or importer has taken responsibility for confirming the product meets all applicable EU essential requirements when it was placed on the EU market. The manufacturer must have carried out a conformity assessment, compiled technical documentation, signed a Declaration of Conformity and, where required, involved a Notified Body from the NANDO database. CE Marking is not a quality mark and not a certification mark.

Is CE Marking mandatory?

CE Marking is mandatory only for products covered by specific EU harmonisation legislation that requires it. More than 25 pieces of EU legislation across the New Legislative Framework require it, including toys, electrical and electronic equipment, machinery, pressure equipment, personal protective equipment, medical devices, construction products, radio equipment, gas appliances and pyrotechnics. Products outside this scope must not bear the CE mark.

How do I get CE Marking for my product?

There is no central EU body that issues a CE mark. The manufacturer identifies the applicable EU harmonisation legislation, decides whether self-declaration is allowed or a Notified Body assessment is required, gathers compliance evidence via testing against harmonised standards, compiles technical documentation, signs the EU Declaration of Conformity and affixes the CE mark to the product or its packaging. There is no fee for the CE mark itself.

What is the difference between CE Marking and UKCA?

CE Marking is the EU conformity mark for products placed on the market in the EU, EEA, Turkey and Northern Ireland. UKCA is the UK conformity mark introduced after Brexit for the Great Britain market. On 1 August 2023 the UK government announced the indefinite recognition of CE marking for most product categories placed on the GB market. UKCA remains available as an alternative but is not mandatory for most categories.

What is a Notified Body?

A Notified Body is an independent organisation authorised by an EU member state and notified to the European Commission to carry out third-party conformity assessment tasks defined in EU harmonisation legislation. Notified Bodies are listed in the NANDO database. If a Notified Body is involved in the conformity assessment procedure, its four-digit identification number must be affixed next to the CE marking on the product.

What is the NANDO database?

NANDO stands for New Approach Notified and Designated Organisations. It is the European Commission public database listing all Notified Bodies authorised to perform third-party conformity assessment under specific EU harmonisation legislation. Importers should search NANDO by product category or legislation to verify that a Notified Body claimed by a Chinese supplier is authentic, still active, and authorised for the specific directive and procedure applicable to the product.

What must the EU Declaration of Conformity contain?

The EU Declaration of Conformity is a signed statement by the manufacturer or authorised representative listing the product identification, the applicable EU harmonisation legislation, the harmonised standards or technical specifications used, the Notified Body identity and four-digit number if involved, and the name and function of the signatory. The declaration must be kept up to date and retained for at least 10 years after the last unit is placed on the market.

How long must technical documentation be kept?

Technical documentation supporting the CE Marking must be retained by the manufacturer, authorised representative or importer for at least 10 years after the last unit is placed on the EU market. The documentation must be available in paper or electronic form, in general reside within the EEA, and be provided to any competent national market surveillance authority on request during that period.

Does CE Marking apply to imports from China?

Yes. Any product from China within the scope of EU harmonisation legislation requiring CE Marking must be CE marked, with technical documentation compiled, the EU Declaration of Conformity signed, and the Notified Body four-digit number affixed next to the CE mark where required. The EU importer of record shares legal responsibility with the manufacturer and must keep the documentation available to market surveillance authorities on request.