CE Marking · Product conformity assessment
Support on the Path to CE Marking
CE marking is a manufacturer's declaration that a product meets the applicable EU regulatory requirements for safety, health and environmental protection. It is not ISO certification of a management system, but a mark affixed to the product itself. We help prepare technical documentation and carry out conformity assessment — the scope depends on the product and applicable regulation.
What does CE marking represent?
CE marking indicates that a product meets the applicable requirements of the relevant EU directives or regulations, and that the manufacturer has carried out the prescribed conformity assessment before placing the product on the market. Responsibility for the accuracy of that declaration rests with the manufacturer (or its authorized representative) — CE marking is not a quality award or a guarantee of superior quality, but confirmation of compliance with minimum regulatory requirements.
What the real CE marking looks like
The CE marking is not a logo anyone may redraw. Its form is prescribed: both letters are sections of the same circle and are of equal height, and when the marking is enlarged or reduced the proportions of the official drawing must be kept. The minimum height is 5 mm, unless the legislation for a specific product says otherwise. The marking must be visible, legible and indelible, and it is affixed before the product is placed on the market. Where a notified body was involved in the production control phase, its four-digit identification number follows the marking.
A story has circulated for years that the squeezed letters stand for “China Export” and that this is a separate Chinese mark. The European Commission has answered parliamentary questions stating that no such mark exists — it is registered nowhere and prescribed nowhere, and what appears on cheap products are CE markings that do not respect the prescribed dimensions and proportions. The practical consequence is more serious than the legend: an incorrectly drawn marking is itself a non-conformity and grounds for market surveillance action, whether it came about through ignorance or on purpose.
So the spacing between the letters is not what you should be dwelling on. The marking alone proves nothing — behind it there must be an EU declaration of conformity naming the legislation and standards the manufacturer relies on, the technical documentation, and, where required, a notified body whose identification number can be checked in the NANDO database. If a supplier cannot send you the declaration of conformity, the marking on the product tells you nothing — however tidy it looks.
When might it be required?
CE marking applies only to products covered by the relevant EU regulation — for example machinery, electrical and electronic equipment, medical devices, construction products, pressure equipment, toys and personal protective equipment. Whether your product is covered, and by exactly which regulation, depends on its intended use, characteristics and target market — this is the first thing we determine together before any further action.
General conformity assessment process
The exact procedure depends on the product category, but generally covers the following steps:
The role of the notified body
For lower-risk products, the manufacturer often carries out the conformity assessment itself (self-certification) and issues a declaration of conformity without involving a third party. For certain product categories and assessment modules prescribed by regulation, the involvement of an independent notified body is mandatory, carrying out testing, technical-documentation review or quality-system certification. We do not issue CE marking or act as a notified body — we help prepare documentation and coordinate with the relevant bodies when needed.
Our scope of support
Determining which regulation and harmonized standards apply to your product.
Help preparing the technical file and the declaration of conformity.
Directing you to the appropriate laboratories and, where needed, notified bodies.
Where one exists, a system such as ISO 9001 or ISO 13485 makes it easier to maintain compliance over time.
Related standards
For medical-device manufacturers, ISO 13485 is closely linked to the CE process under the EU MDR/IVDR regulations. ISO 9001 provides a general quality framework that makes it easier to maintain compliance.
Tailored training for teams involved in product development and preparing conformity documentation.
FAQ about CE marking
Does every product need CE marking?
No. CE marking applies only to product categories covered by the relevant EU directives and regulations. Whether it applies to your product depends on its intended use, characteristics and target market.
Is CE marking the same as ISO certification?
No. CE marking is a manufacturer's declaration that a product meets the applicable EU regulatory requirements, and it is affixed to the product itself; ISO certification concerns an organization's management system. A system such as ISO 13485 or ISO 9001 can support, but does not replace, the CE process.
Is a notified body always required for CE marking?
Not always. For many lower-risk products the manufacturer carries out the conformity assessment itself and issues a declaration of conformity. A notified body is required only for certain product categories and assessment modules prescribed by the applicable regulation.
How much does support with the CE assessment process cost?
There is no fixed price — it depends on the product, the applicable regulation and the scope of testing required. Send us a short description of your product for an indicative quote.
📋 Check the exact price for your product →Check your organization's readiness
Answer a few questions and receive an indicative assessment of your organization's current level of readiness for CE marking.
This self-assessment provides an indicative readiness result only. It does not constitute certification, an official audit, or formal confirmation of compliance.
The EU, the US and other markets
CE marking is the same standard wherever you certify it — what differs is the designation, the accreditation behind the certificate and what your customers ask for.
In the European Union the standard is adopted with an EN prefix, and what your buyer in the Netherlands, Germany or France looks at is not the prefix but the accreditation behind the certificate: a body accredited by a signatory of the international recognition arrangement (Global Accreditation Cooperation, formerly IAF) is recognised in other markets too. What EU partners and EU regulation expect is on the page about the EU market.
For companies with customers in the United States — supplier audits, security questionnaires and how ISO sits alongside SOC 2 — see the page about the US market.
Wherever your customer is, we run the project remotely in English — over Teams, WhatsApp or Viber, with documentation and records in English — and on site when that is easier.
Some of our references
More than 400 organisations in Montenegro and the region have gone through implementation with us — from banks and public bodies to manufacturing, IT, laboratories and hospitality.
These are only some of our clients. More about us →
Request a free consultation
We will assess the scope of work and propose a realistic plan and budget for your product. Call us or send an inquiry — we reply within 24 hours.