CE Marking (EU) — Requirements & Support
Manufacturer outside the EU?
If your company is located outside the EU, you may need EU Authorised Representative services to place products on the EU market and to respond to market surveillance requests.
EU-based manufacturer? Continue below — we can still support documentation and conformity assessment readiness.
CE marking is required for many product categories sold in the European Economic Area (EEA). It indicates that a product complies with
applicable EU harmonisation legislation and can be placed on the EU market.
Request CE marking support
What CE Marking Is — and What It Is Not
- CE marking is not a quality label and not a “certificate issued by the EU”.
- In many cases it is the manufacturer’s declaration (EU Declaration of Conformity) supported by evidence.
- For certain product categories, a Notified Body is required — we help you determine the correct route.
Do You Need CE Marking for Your Product?
CE marking applies only to products covered by specific EU directives/regulations (harmonisation legislation). A correct assessment starts with:
- Product definition and intended use
- Applicable EU acts and harmonised standards
- Conformity assessment route (self‑assessment vs. Notified Body)
Common EU Directives & Regulations (Examples)
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
- PPE Regulation (EU) 2016/425 — Personal Protective Equipment
- Pressure Equipment Directive 2014/68/EU — PED
- Toys Directive 2009/48/EC — Toy safety
- RoHS 2011/65/EU — Restriction of Hazardous Substances
If you need a broader EU market access overview, see:
European product certification.
EU Economic Operator: Critical for Compliance (Marketplaces)
For many products offered to EU consumers (including online sales), an EU economic operator must be identifiable
(e.g., manufacturer, importer, authorised representative, or fulfilment service provider). This is a common reason why products are blocked
or challenged during market surveillance checks.
We help you set up the correct model and ensure labeling/IFU and documentation are aligned with it.
CE Marking Process (Step‑by‑Step)
- Identify applicable legislation (directives/regulations) and scope.
- Identify essential requirements and relevant harmonised standards.
- Risk assessment (per applicable standards).
- Testing and evidence (test plan + reports where required).
- Technical documentation (technical file) and traceability.
- EU Declaration of Conformity (DoC) and internal controls.
- CE marking & labeling/IFU final review and release.
When Is a Notified Body Required?
Some products can be self‑assessed by the manufacturer. Others require a Notified Body due to the conformity assessment modules,
risk level, or specific legislation.
- We determine whether Notified Body involvement is required.
- We support preparation and communication if a Notified Body route applies.
What We Deliver
- Regulatory scope assessment (applicable acts + standards)
- Compliance roadmap and conformity assessment route
- Testing strategy and coordination (where needed)
- Technical documentation (technical file) preparation/review
- EU DoC drafting and consistency checks
- Labeling/IFU review (incl. operator details and traceability)
FAQ
Is CE marking always required?
No. CE applies only to products covered by EU harmonisation legislation. We help confirm applicability.
Can I sell in the EU without CE marking?
If CE marking is required for your product category, selling without CE is not legal and can lead to enforcement actions.
How long does CE marking take?
Timelines depend on product complexity, readiness of documentation, and whether a Notified Body is required.
Start CE marking
