Which Certification Is Required for Products Sold in Europe?

A Complete Guide for International Businesses Entering the EU Market

The European Union is one of the most highly regulated trade zones in the world. If you want to sell products in the EU, high-quality manufacturing alone is not enough — your products must fully comply with European health, safety, environmental, and performance standards. This guide covers every major certification and regulation you need to know, from CE marking and chemical compliance to new digital requirements.​

CE Marking: The Gateway to the EU Market

CE marking (“Conformité Européenne”) is the most important conformity label for products sold in the European Economic Area (EEA). It indicates that a product has been assessed and meets EU requirements for safety, health, and environmental protection. CE marking is not a quality mark — it is a legal declaration by the manufacturer that the product complies with all applicable EU legislation.

CE marking is mandatory for more than 20 product groups, including:​

• Electrical and electronic equipment (Low Voltage Directive, EMC Directive)

• Machinery (Machinery Directive)

• Toys (Toy Safety Directive)

• Medical devices (Medical Device Regulation – MDR)

• Personal protective equipment (PPE Regulation)

• Construction products (Construction Products Regulation)

• Pressure equipment (Pressure Equipment Directive)

• Radio and telecommunications equipment (Radio Equipment Directive)

• Gas appliances, lifts, pyrotechnic articles

• Measuring instruments and non-automatic weighing instruments

• Recreational craft and personal watercraft

• Batteries (from February 2024 under Regulation (EU) 2023/1542)​

Important: CE marking must not be applied to products that are not covered by CE-relevant directives. Doing so is illegal and considered deception.

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How to Obtain CE Marking

There is no central EU authority that issues a CE certificate. Instead, the manufacturer must complete the following steps:​

1. Identify applicable EU directives and regulations — A single product can fall under multiple directives (e.g., a wireless toy may require compliance with the EMC, Radio Equipment, and Toy Safety Directives simultaneously).​

2. Conduct a risk assessment — Identify and mitigate potential hazards in accordance with EU requirements.

3. Test the product — Use accredited laboratories for safety testing (EMC, electrical safety, mechanical durability, chemical compliance, etc.).​

4. Compile technical documentation — This must include product descriptions, manufacturing processes, test reports, risk analyses, applicable standards, and user manuals.​

5. Draft and sign an EU Declaration of Conformity (DoC) — This legally binds the manufacturer to the compliance claim.​

6. Affix the CE marking — The marking must be visible, legible, and indelible, with a minimum height of 5 mm.​

When Third-Party Assessment Is Required

For higher-risk products such as medical devices, pressure equipment, personal protective equipment, and ATEX equipment, conformity assessment by an independent Notified Body is mandatory. You can search for a suitable Notified Body in the EU’s NANDO database. If a Notified Body is involved, its 4-digit ID number must appear next to the CE marking on the product.

For low-risk products, the manufacturer can conduct a self-assessment without involving a third party.​

General Product Safety Regulation (GPSR)

Since December 13, 2024, the new General Product Safety Regulation (EU) 2023/988 has replaced the older General Product Safety Directive. It applies directly in all EU Member States without requiring national transposition.​

The GPSR acts as a “safety net” — it covers all consumer products and addresses risks not already covered by sector-specific legislation like the CE directives. Key changes include:​

• Broader product coverage: Applies to products sold online, used, repaired, or reconditioned products as well.​

• Mandatory risk assessments: Economic operators must conduct rigorous risk assessments throughout the product lifecycle.​

• Enhanced technical documentation: Manufacturers must prepare and maintain documentation for 10 years, now including cybersecurity and AI-related features.​

• Mandatory manufacturer labeling: Products must display the manufacturer’s name, postal address, and an email address or website URL.​

• Consumer recall rights: Consumers now have the right to claim remedies from the responsible party in the event of a product recall.​

EU Responsible Person / Authorised Representative

One of the most critical requirements for non-EU businesses: if you are a manufacturer based outside the EU, you must appoint an EU-based Responsible Person or Authorised Representative.

Under the GPSR, every product on the EU market must have an EU economic operator responsible for it. This can be a manufacturer, importer, authorised representative, or even a fulfilment service provider based in the EU. Without this, you risk:​

• Customs clearance issues — Products may be blocked at the EU border.​

• Marketplace delistings — Amazon, eBay, and other platforms may remove non-compliant listings.​

• Regulatory penalties — Fines and legal action.​

Responsibilities of the EU Authorised Representative

• Maintaining the product’s technical documentation and Declaration of Conformity for 10 years​

• Cooperating with national authorities during inspections​

• Assisting in corrective measures such as recalls​

• Ensuring their name, address, and contact details are displayed on the product, packaging, or accompanying documentation​

REACH: Chemical Safety Regulation

REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals — Regulation (EC) No 1907/2006) is Europe’s comprehensive chemical regulation, in force since 2007. It requires:​

• Registration: All chemicals manufactured in or imported into the EU must be registered with the European Chemicals Agency (ECHA) if the annual volume exceeds 1 metric ton.​

• Evaluation: ECHA evaluates substances of concern for potential health and environmental risks.

• Authorisation & Restriction: The most dangerous substances (SVHCs — Substances of Very High Concern) may be restricted or require authorisation for continued use.

REACH applies to all products — not just chemicals — because any article containing substances above 0.1% concentration of an SVHC on the Candidate List must communicate this information down the supply chain. Unlike CE marking directives, REACH does not require a CE mark, but compliance is essential for legal market access.

RoHS: Restriction of Hazardous Substances

The RoHS Directive (Restriction of Hazardous Substances, Directive 2011/65/EU) complements the WEEE Directive by banning certain hazardous substances in electrical and electronic equipment (EEE). Restricted substances include:​

• Lead, mercury, cadmium

• Hexavalent chromium

• Polybrominated biphenyls (PBB) and polybrominated diphenyl ethers (PBDE)​

Products that comply with RoHS must carry the CE marking. RoHS compliance is mandatory for all EEE sold in the European Economic Area.​

WEEE: Waste Electrical and Electronic Equipment

The WEEE Directive (Directive 2012/19/EU) focuses on the end-of-life management of electronic products. It obligates manufacturers, importers, and distributors of electronic equipment to:​

• Label products with the crossed-out wheeled bin symbol for recycling identification

• Finance the collection, treatment, and recycling of electronic waste

• Register with national WEEE registries in each EU country where products are sold​

This directive applies to a broad range of electronic products — from consumer electronics to industrial equipment. Non-compliance can lead to fines and market bans.

Cyber Resilience Act (CRA)

The EU Cyber Resilience Act is a new regulation that introduces mandatory cybersecurity requirements for all products with digital elements — including IoT devices, software, and networked hardware. Key requirements include:​

• Security by design: Cybersecurity must be integrated into the development process (e.g., no default passwords like “password”).​

• Vulnerability management: Manufacturers must handle vulnerabilities for the entire support period and report actively exploited vulnerabilities.​

• CE marking for digital products: Products must now meet CRA cybersecurity requirements as part of the CE conformity assessment.​

• Third-party assessment: Higher-risk digital products (e.g., password managers, VPN software, smart home devices) and critical products (e.g., smart meter gateways, security chips) may require Notified Body assessment.​

The CRA is particularly relevant for tech companies and IoT manufacturers planning to enter the EU market.

Ecodesign (ESPR) and Digital Product Passport

The Ecodesign for Sustainable Products Regulation (ESPR) came into force on July 18, 2024 and replaces the former Ecodesign Directive. It dramatically expands the scope from only energy-related products to nearly all physical goods placed on the EU market.​

What the ESPR Requires

• Products must meet binding sustainability criteria, including durability, reparability, recyclability, and energy efficiency.​

• Priority product groups (2025–2030): textiles, furniture, consumer electronics, tyres, iron/steel, aluminium, plastics.​

Digital Product Passport (DPP)

A cornerstone innovation of the ESPR: every regulated product will carry a Digital Product Passport — a digital record, typically accessed by QR code, that provides sustainability data, composition details, and lifecycle information. This enables transparency for manufacturers, consumers, repairers, and recyclers. The first delegated acts are expected from 2027 onwards.

Labeling and Language Requirements

EU labeling regulations require products to include specific information that must be clear, legible, and in the official language(s) of the country where the product is sold. Mandatory label content typically includes:​

• Manufacturer identification (name, trade name, postal address)​

• EU economic operator details (for non-EU manufacturers)​

• Product identification (model, batch, lot, or serial number)​

• Safety information and warnings in the local language(s)​

• Contact information (email, phone, or web form)​

For products with limited space, remaining details may appear on the packaging or accompanying documentation. Failing to comply with labeling requirements is one of the most common reasons products are rejected at EU borders — a European Commission study found that over 30% of products initially failed compliance checks due to labeling errors.

EORI Number: Customs Registration

Any business importing goods into the EU must have an EORI number (Economic Operators Registration and Identification). This unique identifier is mandatory under the Union Customs Code and is required for filing customs declarations.​

• EU-based businesses must obtain their EORI number from the national customs authority in their country of establishment.​

• Non-EU businesses that ship goods to the EU do not always need their own EORI number but must provide the recipient’s or importer’s EORI number on the commercial invoice.​

• Each business receives one single EORI number that is valid across the entire EU.​

Without a valid EORI number, goods can be blocked at customs, causing delays and potential fines.​

Sector-Specific Requirements

Beyond the general frameworks above, certain product categories have additional regulations:

Technical Documentation and Declaration of Conformity

Regardless of product category, you will need to prepare two foundational documents for EU compliance:

Technical Documentation (Technical File)

This file must be prepared before placing the product on the market and retained for at least 10 years. It should include:​

• Product description and identification

• Design and manufacturing information

• List of applicable EU directives and harmonised standards

• Risk assessment and mitigation measures

• Test reports from accredited laboratories

• Product labels and user instructions (in relevant EU languages)

• The EU Declaration of Conformity​

EU Declaration of Conformity (DoC)

The DoC is a legal document signed by the manufacturer or authorised representative declaring that the product meets all applicable EU requirements. It must contain:​

• Manufacturer’s name and full business address

• Product serial number, model, or type identification

• A statement of full responsibility

• Details of the Notified Body (if applicable)

• References to all relevant legislation and harmonised standards

• Date and signature

Compliance Checklist for Non-EU Businesses

Here is a practical step-by-step checklist for international businesses planning to sell products in the EU:​

1. Identify all applicable EU regulations — CE directives, GPSR, REACH, RoHS, WEEE, CRA, and sector-specific rules

2. Conduct risk assessments and ensure essential safety requirements are met

3. Have products tested at accredited laboratories

4. Compile technical documentation and the EU Declaration of Conformity

5. Translate labels and instructions into all relevant EU languages

6. Ensure correct labeling and CE marking (where required)

7. Appoint an EU Responsible Person or Authorised Representative

8. Obtain an EORI number for customs clearance

9. Register with national WEEE registries (for electronic products)

10. Prepare for post-market surveillance — monitor regulations, handle recalls, and report safety issues

What’s New and Coming in 2025–2027

Entering the European market requires thorough preparation, but the investment pays off. EU compliance is harmonised across all 27 Member States — meaning once you certify your product, you gain access to one of the largest single markets in the world with over 450 million consumers. With proper planning, accurate documentation, and the right partners in the EU, international businesses can navigate the regulatory landscape efficiently and build lasting trust with European customers.

To easily start selling in Europe, our Merchant of Record service is the best way to do so. With this service we take care of accounting and legal obligations while acting as the selling in Europe – without the need to open a own subsidary.