CE Marking Specialists

We help manufacturers and importers sell their products legally in the EU

Zatisfy becomes Certify & Comply

We are now changing our name to Certify & Comply. However, we will continue to assist you with everything related to CE marking— from training to content and services— to ensure that the CE marking process is as smooth as possible.

We also have a brand new website, and you can now find us at certifycomply.com. If you come across any broken links or notice anything missing on our new site, please feel free to reach out to us at info@certifycomply.com.

How can we assist you with CE marking?

Do you have the world’s best idea, product or design that you’re eager to bring to market but aren’t sure where to start with CE marking? 

Great! We have proven methods to address all these questions related to product safety and CE marking. The CE marking process can be long and challenging, but with our help, it becomes faster and smoother.

We help companies create and sell safe, legal products, and improve the free movement of goods within the EU.

Our business areas within CE marking

We assist companies with CE marking and safety for a wide range of products.

Machine safety

Machines (mobile, stationary, standalone, safety-related systems, or production facilities) can be extremely complex or very simple. We have the experience and expertise needed to make your CE marking process straightforward.

Product safety

This is our largest business area as it covers a wide variety of products. Everything from toys to personal protective equipment, electronic products, and products that do not require CE marking at all are included here.

If you import or manufacture similar products, we can support you on your journey towards legally compliant products.

Medical devices

We cover all areas of medical devices from Class I to Class III. Our internal and external experts can build your quality system and technical documentation from scratch to ensure you meet the requirements of the new MDR and IVDR.

Training in CE marking

CE marking is constantly evolving, and if you work with machine safety or medical devices and want to enhance your knowledge through training, you’ve come to the right place.

If what you do doesn’t fit within these business areas, contact us, and perhaps our extensive network of partners can help you. If you want to know more about Certify & Comply, click here.

CE märke

Complete CE marking assistance

Integrate CE marking into your development process to lower costs. The Certify & Comply experts will work and consult with you to plan a compliance strategy so you can focus on selling in the EU.

Ikon kring säkerhet för CE märkning

Meet all EU safety standards

Regardless of the industry or product, your product will meet all relevant European product directives. With our expert guidance through the regulation process, you avoid sales stoppages, recalls, or fines.

Ikon för ekonomi

Reusable methodology saves money

After using our services for the first project, you can reuse the templates and proceed on your own for future projects. The Certify & Comply team is always here if you need help.

About Certify & Comply

Certify & Comply delivers world-class service to manufacturers, importers, and exporters who want to sell their products in European Union countries.

CE marking & product safety

The CE mark or Conformité Européenne mark (European Conformity in French) is a product label that has been established by the European Commission (EC).

Knowledge base

Read our articles and blog posts to learn the latest from the world of compliance and also get answers to many frequently asked questions.

What clients say

Frequently Asked Questions

Below, we have collected frequently asked questions relating to CE marking. If you do not find an answer to your question, just contact us and we will be happy to help you!

One of the most common points of confusion, from our perspective, is the so-called “Certificate of Conformity”, “Certificate of Compliance” or similarly named documents. These are documents that importers are regularly supplied with, and some manufacturers within the EU want to acquire. While these two certificates have definitions within certain EU-legislations, they often appear in other circumstances.

Such certificates are often brought up by economic operators, who think that their product must be submitted to an authority for certification and, in that manner, be allowed to use the CE mark. This is an understandable misconception, since this is how product compliance works in certain other markets. 

Many of these certificates that we have seen are supplied to manufacturers by test labs. They are essentially summaries of full-length test reports for a specific legislation in these cases. Still, due to the lack of understanding by some actors in the supply chain, they are interpreted as a complete validation of product compliance.

The CE marking process is primarily based on technical documentation and self-declaration, not certification. Although there are certain certificates as stated above, also the most broadly defined certificate “EU type-examination certificate“. The “EU type-examination certificate“ is often an optional alternative to self-assessment, and in certain circumstances it is obligatory.

Now, there is certainly a need for certificates but in general, certificates should never be viewed as especially meaningful without the underlying knowledge to assess the actual content of the certificate.

Economic actors are sometimes surprised by the amount of technical documentation required for their products since there are already similar or identical products on the market. This is especially common for importers who intend to rebrand products under their own trademark. The original manufacturer sometimes assures the importers that other importers have already done the same for the product, and it must already be compliant. 

This effectively displays that too much focus is placed on the “actual” compliance of the product, but disregards the entire technical documentation section of the CE marking process that is meant to prove said compliance.

An economic actor that sells products that have been rebranded under their trademark or “private label” takes up a large part of the responsibility for product compliance (we are inclined to say all responsibility), which is often misunderstood. The fact is that any actor that places their trademark (solely) on a product is considered the manufacturer for all intents and purposes. The actor then has all obligations of a manufacturer, which include having the correct technical documentation and signing the correct declarations.

In these cases, it does not matter if the product under its original trademark was in complete compliance if the private labeller does not have the documentation for their “new” product. This usually goes hand-in-hand with the previous misconception that two private labellers, let’s call them Actor A and Actor B,  purchase the same product from a third-country manufacturer (i.e. outside of the EU/EEA market). 

Perhaps Actor A takes all necessary steps for proving compliance, but Actor B  has seen that Actor A has stated the compliance of their products, and relies on that for proof of their compliance. Actor B will not in fact be in compliance.

Or perhaps Actor A  believes that they are not actually considered the manufacturer and therefore have no technical documentation, but the product is still CE marked. Actor B  has seen that the product is on the market and assumes that the CE mark is correctly applied. Actor B then orders their product batch, assuming that its compliance can be proven. Still, drawing up the technical documentation, they find that the product is non-compliant in design and must be discarded.

It is therefore essential for private labellers to understand their legal obligation. And also, it is incredibly important that the technical documentation and compliance testing are done before ordering anything larger than a sample batch and that no assumptions of compliance  are made..

It is the manufacturer’s sole responsibility to draw up the technical documentation and accompanying declarations (for specific legislations, an Authorised Representative can be mandated to draw up some of the documentation). But this does not mean that other actors are free of obligations. A due diligence system is defined in many legislation under the “Obligations of Economic Operators,” where commonly, importers and distributors hold the responsibility to verify that the manufacturer has performed certain tasks. 

Importers must essentially verify that the manufacturer has completed every obligation to show compliance including verifying that the product has the technical documentation. 

Distributors hold a lesser degree of responsibility; they must only verify that all information that reaches the customer is in place. This includes accompanying documents, labelling, and, when applicable, that the product is CE marked.

No actors except the consumer/end-user (except ancillary actors, e.g. transport) are therefore allowed to “trust” or “assume” that the product is compliant. Therefore, they must take the same steps to ensure that the product they import or distribute comply.

Vill veta mer?

Om du vill veta bättre hur Zatisfy kan hjälpa till med att följa EU:s marknadslagstiftning, läs gärna mer här, skicka ett mail till contact@zatisfy.se eller boka ett kostnadsfritt 25 min möte med någon av våra experter här.

CE marking is required for various product groups, including electronics, toys, medical devices, personal protective equipment and machinery. It depends on whether the product falls within the scope of a CE marking directive.

The time it takes to CE mark a product varies depending on the product type and how far you have come. It can take from a few weeks to several months or years.

It depends on the product type and whether it is covered by CE marking directives within the EEA.

Yes, in fact it is the case that a manufacturer ALWAYS CE marks. Manufacturers CE mark themselves by following the necessary procedures and standards. Often it involves testing and documentation and only occasionally external certification is required.

CE stands for “Conformité Européenne” in French, which means “European Conformity”.

Products covered by specific EU directives and regulations require CE marking.

The product can not be sold on the market within the EEA, and the manufacturer may face legal consequences. This may result in the product being discontinued and recalled.

Within the EEA, a machine covered by the requirements may not be sold or used on the market if it is not CE marked.

The cost varies depending on the product type and scope and varies from SEK 0 to 1 million or even more. It often includes testing, documentation and possible certification. Read more in our article about costs here.

Not all clothing has to be CE marked. It depends on whether they are covered by relevant directives, such as personal protective equipment.

Yes, if the machine is covered by relevant directives within the EU.

A written declaration from the manufacturer that declares that the product complies with applicable laws and regulations.

When the user needs information to use the product safely and effectively, then a product covered by the GPSD  (General Product Safety Directive) needs a manual.

Instructions or manuals must always be translated into the language(s) applicable in the country determined by the Member State where the product is sold.

A recall refers to a process where a manufacturer, importer or distributor withdraws a product from the market. This is usually done when it has been discovered that the product poses a risk to consumers or does not meet safety standards or regulatory requirements. There are both voluntary (where the manufacturer himself decides to recall) and forced (where a market control authority makes the decision) recalls.

The manufacturer, importer or distributor pays all costs for a recall.

CEmärkning av maskiner och byggutrustning

Industries we serve

Our CE Marking specialists can help your products become EU Market Compliant. Click on the following categories to see how we can help your product.

Do you need a coach to guide your development team? We provide consultation services and CE Marking coaching for functional, automation, product, and plant safety.