CE marking certification support, with the notified body in one package

What the CE marking package includes

CE marking shows that a product meets the EU legislation that applies to it. It is required for products in scope of that legislation before they are placed on the market in the European Economic Area. The mark is applied by the manufacturer, who signs an EU Declaration of Conformity and keeps a technical file ready for market surveillance authorities.

For some products the manufacturer can declare conformity alone. Others, depending on the directive and the product's risk, need an independent notified body to examine the design, test a type or audit production. Our package covers both cases.

• Identification of the directives and regulations that apply to your product
• Selection of the harmonised standards that give presumption of conformity
• Risk assessment documented with a recognised method
• Technical file preparation: description, drawings, components, test reports, manuals and labels
• Test coordination with accredited laboratories
• Choice of conformity assessment module and, where needed, submission to a notified body
• Drafting of the EU Declaration of Conformity and guidance on affixing the mark

If you already sell in Europe and only need to check an existing file, we can review it against the current standards and tell you what is missing, instead of starting from zero.

Self-declaration or notified body: the options in plain terms

Every CE directive or regulation lists the conformity assessment procedures, called modules, that apply to the products it covers. Module A is internal production control: the manufacturer tests, documents and declares conformity without a third party. Many products under the Low Voltage Directive, the EMC Directive or the Machinery Directive for machines not listed in its annex follow this route.

Other modules involve a notified body: an EU-type examination of a representative product, an audit of the production quality system, product verification, or a full quality assurance assessment. Pressure equipment in higher categories, certain machinery, personal protective equipment of higher categories, lifts, gas appliances and most medical devices fall here.

Choosing the right module matters for both legal validity and cost. A notified body must also be designated for your directive and module; a certificate issued outside its designated scope is not valid. We check the designation in the EU NANDO database before submission.

Whichever route applies, the responsibility for the product stays with the manufacturer. No consultant can promise that a notified body will issue a certificate; what we commit to is a complete, consistent file that answers the requirements.

What decides the package price

CE marking packages with EUROTECH start at $800. The price includes our consultancy and, when your product needs a notified body, the notified body fees, so you have one figure to budget.

• Number of directives and regulations that apply, for example Machinery plus EMC plus RoHS
• Conformity module: self-declaration, type examination or quality system assessment
• Testing needs and whether you already hold valid test reports
• Number of product variants covered by one file
• State of your documentation: drawings, manuals and component data

We confirm the price in a written quote after a short review of your product, its intended use and your existing documents.

Two things keep the cost down: complete design documentation from the start, and test reports from accredited laboratories that already cover the current versions of the harmonised standards. Reports that cite withdrawn standard versions often have to be redone.