What people ask when placing a product on the market

Conformity assessment is the process by which the manufacturer demonstrates that a product meets the requirements of EU legislation. You identify the applicable directives and regulations, choose the conformity assessment procedure, carry out testing and compile the technical documentation. Only then does the manufacturer issue the declaration of conformity and affix the CE marking.

The order matters: the declaration is the last step, not the first. What a declaration must contain →

In most cases the manufacturer can carry out the conformity assessment themselves. After identifying the legal requirements they compile the technical file and issue the declaration of conformity on that basis.

In the remaining cases a conformity assessment body — a notified body — must be involved. That applies, for example, to selected categories of machinery, pressure equipment and higher-class medical devices.

There is no simple answer to this — much like asking what a car costs. Certification itself can range from a few thousand Czech crowns to hundreds of thousands.

The price is driven by the conformity assessment procedure chosen, by which documents already exist for the product, and by how much assistance you expect from us. Once we have a description of the product we will give you a range at the first consultation.

Templates exist — our guide at MyCECheck.com walks you through one step by step and can also review a declaration you already have.

But every declaration differs according to the specific legal requirements for the product. And above all: a template does not replace the technical file the declaration is based on. A filled-in form without supporting documents will not survive an inspection.

It depends on the nature of the product and on the legal requirements, but you are always in breach of the manufacturer's obligations. In the Czech Republic these are set out in Section 6(2) of Act No. 90/2016 Coll.:

The manufacturer is obliged to draw up technical documentation and to carry out, or have carried out, the conformity assessment procedure laid down by government regulation. […] Once conformity has been demonstrated, the manufacturer is obliged, in the cases laid down by government regulation, to draw up an EU declaration of conformity or another document confirming conformity and to affix the CE marking or another prescribed marking. They are obliged to retain the technical documentation and the declaration of conformity to the extent and for the period laid down by government regulation.

If an inspection has already taken place, see the Inspection page.

It depends on the legal requirements for the specific product, but it is always in the manufacturer's interest to monitor feedback from the market, evaluate complaints and keep improving the product.

Under Section 6(6) of Act No. 90/2016 Coll., the manufacturer is obliged, in the cases and to the extent laid down by government regulation, to carry out sample testing and other necessary investigations of products placed on the market, to keep a register of complaints, of non-conforming products and of products withdrawn from circulation, and to inform the distributors they supplied.

As a rule ten years from placing the product on the market. The surveillance authority may request it at any time during that period — long after production has ended.

They are the same type of document, only under legislation of different ages. Older directives speak of an “EC declaration of conformity”, legislation of a more recent date of an “EU declaration of conformity”. What matters is the wording of the legislation applicable to your product.