European Product Certification & EU Market Access

Planning to sell products in the European Union? In most cases you must demonstrate compliance with applicable EU product legislation, prepare technical documentation, and ensure the correct EU economic operator setup before placing products on the EU market.

Start Here (3 Steps)

1. Define the product and intended use (what it is, how it is used, target users, operating environment).
2. Identify applicable EU legislation and standards (directives/regulations + harmonised standards).
3. Build your compliance plan (testing, risk assessment, labeling/IFU, technical file, EU Declaration of Conformity).

Request a compliance assessment

What “EU Certification” Typically Includes

• Regulatory scope assessment (which acts apply and why)
• Conformity assessment route (self‑assessment vs. Notified Body involvement)
• Technical documentation (technical file) and evidence package
• Risk assessment and testing plan (harmonised standards where applicable)
• Labeling/IFU review (incl. traceability and operator details)
• EU Declaration of Conformity (DoC) and CE marking (where required)

Common EU Directives & Regulations (Examples)

The exact list depends on your product. Below are typical examples (non‑exhaustive):

• LVD 2014/35/EU — Low Voltage Directive
• EMC 2014/30/EU — Electromagnetic Compatibility
• RED 2014/53/EU — Radio Equipment
• Machinery Regulation (EU) 2023/1230 — Machinery
• RoHS 2011/65/EU — Restriction of Hazardous Substances
• Pressure Equipment Directive 2014/68/EU — PED
• ATEX Directive 2014/34/EU — Equipment for explosive atmospheres
• Toys Directive 2009/48/EC — Toy safety
• CPR Regulation (EU) No 305/2011 — Construction Products
• Cosmetics Regulation (EC) No 1223/2009 — Cosmetic products
• MDR (EU) 2017/745 and IVDR (EU) 2017/746 — Medical devices and IVD
• Market Surveillance Regulation (EU) 2019/1020 — compliance framework and EU economic operator requirements for many products
• General Product Safety Regulation (EU) 2023/988 (GPSR) — consumer product safety (where applicable)

EU Economic Operator: A Key Requirement (Especially for Marketplaces)

For many products offered to EU consumers (including online sales), you must ensure an EU economic operator is identifiable (e.g., manufacturer, importer, authorised representative, or fulfilment service provider). This is a frequent reason why products are blocked or challenged during market surveillance checks.

• We help you select the correct EU role and align labels/IFU and documentation accordingly.
• If you are a non‑EU manufacturer, you may also need an EU Authorised Representative depending on the applicable legislation.

What We Deliver

• Compliance scope & roadmap: applicable acts + standards + conformity route
• Technical documentation structure: templates, checklists, and technical file review/build
• Testing strategy: what to test, where, and how to document results
• Labeling/IFU review: CE marking, warnings, traceability and operator details
• EU Declaration of Conformity: drafting and consistency checks
• Notified Body support (when required): preparation and coordination

Typical Timelines (Indicative)

• Simple products: often a few weeks once documentation and samples are available
• Complex / multi‑directive products: typically 1–3 months depending on tests and documentation readiness
• Notified Body route: timelines vary and depend on capacity and scope

FAQ

Do all products need CE marking?

No. CE marking applies only to products covered by specific EU harmonisation legislation. We help confirm whether CE is required and which acts apply.

When do I need a Notified Body?

It depends on product category and conformity assessment route. Some products can be self‑assessed; others require third‑party involvement.

Can I sell via an EU marketplace without an importer?

In many cases, you still need a compliant EU economic operator setup and correct traceability information. We help structure this correctly to reduce enforcement risk.

Start EU market access