For manufacturers and distributors, we support EU regulatory strategy, conformity assessment planning, documentation readiness and evidence coordination — so you can enter and stay on the EU market with fewer surprises.
Clear scope · Practical roadmap · Documented responsibilities · Response in 1–2 business days
Takes 2–3 minutes. No obligation.
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.
If your project also involves testing, certification bodies, EU AR support, or comparing multiple compliance routes, use Eucertify.eu as the wider entry point.
CE marking is not just a label — it is a compliance statement with real responsibilities. Getting it wrong can lead to customs holds, marketplace takedowns, surveillance actions, recalls, and contractual issues.
Regulatory responsibilities differ by role (manufacturer, importer, distributor) and by sector legislation. We help you map what applies, prepare a workable compliance plan, and avoid the common “paper CE” pitfalls.
Most CE projects fail not because a product is unsafe, but because the evidence chain is incomplete: requirements → design decisions → risk controls → verification/testing → labeling/IFU → declaration.
Identify applicable EU legislation (sector regulation/directive), intended use, and any borderline issues. This determines obligations, timelines, and whether a Notified Body is required.
Choose harmonised standards where available and build a clear mapping to essential requirements. This is where many “template” technical files break.
Risk analysis must match the product and the real use conditions. Testing and calculations should trace back to the risks and to the requirements you claim compliance with.
Build a technical file that can survive a market surveillance request: consistent identifiers, controlled revisions, traceability, and evidence that matches the claims you make.
The DoC is your legal statement of compliance. It must be correct, complete, and aligned with the exact legislation/standards and product identifiers used on labels and packaging.
Selecting the right body is often a long and difficult process (scope, designation, capacity, timelines). But it is critical — it can determine the speed, cost, and predictability of your certification project.
If you tell us your product type and target EU countries, we can propose a practical compliance route, document list, and a realistic timeline.
Want to enter the European market with your products? Learn what you need to know about EU compliance requirements.
What is CE marking? Why is it needed? Who needs it? Understand the CE mark and certification process.
What assistance can we provide to help you comply with all legal requirements for the EU market.