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CE Marking

There a numerous products need to be CE declared while putting to the market of European Union. Putting the CE sign on a product and issuing the so called declaration of conformity is a mandatory to be done by the product manufacturer. Or his authorized representative in EU (like importer company, partner company, agent etc.).

The whole process of declaring the product to be compliant with the relevant EU directive is a well know story. Well, everybody says that. Don't know if you know the story already but here are some interesting things to conclude.

Process starts with the presumption you are aware you need this declaration. Need might come from the end customer (they are asking for it), your partners (during site erections, starting the business co-operation etc.), custom duty (they asked you for one during import in EU) or authorities (inspections of market surveillance).

May be you don't need it. Take a look on a „new approach“ EU directives and find specific product range that needs to fulfill the conformity with the relevant standards and safety issues.

If you need it (probably yes, because you feel it in your „belly“ while reading this article), you will need to comply with the key requirements regarding your product type. Product type means you need to study the mandatory requirements for your particular product and follow the appropriate directive and harmonized standards.

First suggestion is to read the directive(s) your product(s) need to comply. The appropriate directives you can find on a web site of European commission. And you can find it on one of the official EU languages. English is included of course (no matter the Great Britain is out of the game after Brexit). Do not overlook the harmonized standards mentioned inside. At least take a note and write it to your memo. You will need it.

Then take a surf on the internet, find as much information you can regarding the procedure, experience and applied standards with the respect of your product. Do not hesitate to ask a professional help to avoid misleads or doubts regarding the scope of requirements, importance of harmonized standards or ideas about the application for the quality check.

Next and most important thing is a list (not internet) of things you must prepare for completing the process. Most products might fall under the simple quality check schema. Some other might need a product attestation. Some other type examination. All this schema are different and need different approach.

What is sure you will need is a product technical documentation (including descriptions, drawings, technical specifications, components certificates or declarations of conformity, user manual, naming plate etc.), risk assessment, declaration of conformity and of course, your product.

There is an important distinguish between CE compliant product and the one that is compliant but not CE marked. The second one is called „manufacturer declaration“ and it usually falls under the term „unfinished product“. Unfinished product means there is something else needed to be done on your product to be fully functional and capable to be CE marked. It usually takes a control device(s), safety device(s), connection to an external control system (like in building), accompanied with some other product or device etc. Both CE marked and „unfinished product“ fall under the same directive but usually under different Annex. But both are matter of investigation and interest during the compliance procedure.

Next big issue is a user manual. The content of user manual should have all the mandatory requirements, mainly for the safety issues. Also, the technical documentation must consist of all the relevant documents that supports the story of your product compliance. It is like an additional support to your product characteristics-if it is built with the compliant components, it can be concluded that there is a big chance your final product is compliant too.

Sometimes it is needed to do the attestation or type examination by the notified body. The list of notified bodies authorized by the European Commission is listed on the official web site of EC. Be aware of notified body you planned to choose for the test is certified and has been accredited for the appropriate directive. Type test usually includes check on site or by the authorized representative in EU. During the test, the safety of the product is checked and approved. Together with all the relevant technical documents and component certificates. Be aware that technical data file as a key stone of product conformity assessment is not needed to be prepared for each product during standard deliveries. The condition is only to be possible to construct the technical data file within a short period of time and to be able to list all the relevant documents it consist of.

Issuing the declaration of conformity and CE marking of a product is a final stage of the certification assessment. The scope of declaration lists all the relevant directive(s) and harmonized standards of a „new approach“. The form is strict and the elements on it are specified in relevant directive. Marking the product with CE sign is a final and very visible sign the process comes to the end. Product itself must be accompanied with the appropriate EC-declaration of conformity or manufacturer's declaration in a technical data file. Marked product is ready for delivery and putting into the EU market.

And at the end, CE marked product and issued declaration is a must on a EU market. Not to be forgotten.

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