CE Certification for the European Union

What is CE Certification?!

CE marking (abbreviation of the French Conformité Européenne "European Conformity") is a specific mark that is affixed to the product and certifies that the product meets the essential requirements of EU directives and the harmonized standards of the European Union and that the product has passed the conformity assessment procedure of the directives.

The CE marking indicates that the product is not harmful to consumers and does not pose a risk to the environment. In the member countries, administrative and criminal sanctions have been introduced for violations of the regulations regarding the use of the marking.

However, it should be noted that the CE mark is not a symbol of product quality. Decision 768/2008/EC (Decision No. 768/2008/EC), adopted on July 9, 2008, regulates the rights and obligations for the application of the CE marking (CE mark).

According to this decision of the European Parliament, there are recommendations to the countries of the European Union for monitoring the EU internal market regarding the sale of products subject to CE marking requirements.

The CE certificate is a document that officially confirms the conformity of products with the safety standards applicable in the European Union. On a voluntary basis, CE certification is applied in Switzerland, Japan, Canada, the USA, Australia, New Zealand, and Israel.

Product Groups Subject to CE Certification

Not all products sold in the countries of the European Union are required to have CE marking. The regulations for CE certification and the affixing of the corresponding CE marking on products are governed by Decision No. 768/2008/EC.

The following product types are subject to the measure:

• Toys – Directive 2009/48/EC
• Construction products – Directive 305/2011/EC
• Personal protective equipment – Directive 89/686/EEC
• Non-automatic scales – Directive 2009/23/EC
• Low voltage equipment, electrical safety – Directive 2006/95/EC
• In vitro diagnostic medical devices – Directive 98/79/EC
• Gas appliances – Directive 2009/142/EC
• Pressure equipment – Directive 97/23/EC
• Electromagnetic compatibility – Directive 2014/30/EU
• Simple pressure vessels – Directive 2009/105/EC
• Lifts and lifting devices – Directive 95/16/EC
• Medical devices – Directive 2007/47/EC
• Machinery and equipment – Directive 2006/42/EC
• Measuring instruments – Directive 2004/22/EC
• New hot water boilers – Directive 92/42/EEC
• Medical products – Directive 90/385/EEC
• Radio equipment – Directive 1999/5/EC
• Explosives – Directive 93/15/EEC
• Funicular railways – Directive 2000/9/EC
• Sports boats – Directive 94/25/EC
• ATEX equipment – Directive 94/9/EC

CE Certification Procedure

The manufacturer of the specified products is obliged to ensure that its products are designed and manufactured in accordance with the requirements of the relevant European standards (harmonized standards) and EU directives applicable to that product. According to Decision No. 768/2008/EC, traders and importers also bear some responsibility for product safety.

Harmonized EU standards prescribe the conduct of conformity assessment of products. The conformity assessment is a procedure for certifying or verifying products, conducted based on modules.

Depending on the type of product, description of the product and its functional characteristics, current or potential risks, and the necessity of involving a third independent party in the conformity assessment, a module for the product conformity procedure is selected.

The CE certification procedure according to European directives is divided into the following modules (conformity assessment schemes):

1. Internal production control – Module A
2. Internal production control with testing at specified intervals – Module A2
3. Internal production control with product testing – Module A1
4. Sampling testing – Module B
5. Conformity of samples with internal production control – Module C
6. Conformity of samples with controlled tests – Module C1
7. Conformity of samples with the production process – Module D
8. Examination of samples at specified intervals – Module C2
9. Quality assurance of the production process – Module D1
10. Conformity of samples based on quality assurance – Module E
11. Quality assurance of product control and testing – Module E1
12. Conformity with the standard sample based on verification – Module F
13. Conformity based on product verification – Module F1
14. Conformity based on individual testing – Module G
15. Conformity based on comprehensive quality assurance – Module H
16. Conformity based on design examination – Module H1

Additional marks and labels may be affixed to products, such as for electrical safety, ATEX, RoHS, fire hazard class, and others. The conditions for affixing additional markings are specified in EU directives.

EU member states should rely on existing mechanisms to ensure the correct application of the CE marking system and take appropriate measures in the event of improper affixing of the CE marking. They should also provide for sanctions for violations, which in serious cases may include criminal penalties.

These penalties should be proportionate to the severity of the offense and serve as an effective deterrent against the misuse of the CE marking. In most cases, the CE certificate is valid for three years and is checked annually. However, there are also certificates issued for ten years or indefinitely, which are only subject to inspection if changes are made to the manufactured products.

Requirements for CE Marking

The CE marking must be at least 5 mm high. The manufacturer can choose the color and method of affixing the marking (label, engraving, etc.). The visibility requirement means that the CE marking should be clearly visible.

It can be affixed to the back or bottom of the product. The visibility requirement does not necessarily mean that the marking should be visible when or before opening the product packaging.

To ensure readability, a minimum height of 5 mm is required. However, according to some legal acts, the minimum size of the CE marking may be waived for small devices or components.

The CE marking must be affixed explicitly, clearly, and permanently on the product or on a special product label. If this is not possible or justified due to the nature of the products, the marking should be affixed to the packaging or indicated in the accompanying documents.

EU Control over Compliance with Requirements

EU member states are obliged to carry out appropriate product controls before they are released for free circulation, to withdraw or destroy non-compliant products, or to request an authorized representative or manufacturer to take corrective measures to meet the requirements.

The control system in the European Union and beyond is becoming increasingly complex and relevant in all countries. In the EU, market surveillance authorities must not only provide a control system for the safety of consumer goods but also conduct checks on product characteristics in accordance with Article 19 (1) of Regulation 765/2008/EC.

This is done both by reviewing documentation – EU certificates, declarations, test reports, and, if necessary, physical and laboratory tests – as well as by examining a product sample.

For example, German law stipulates that the use of one sample per 2,000 inhabitants per year is set as a guideline for each federal state. The financial and other resources required to achieve this goal must be provided from the federal budget.

Recently, the frequency of product recalls without related safety incidents has increased. The main reasons for such recalls are that large retail companies conduct regular conformity tests using accredited laboratories and notified bodies.

Customers and increasingly competitors are becoming more aware of the formal issues of compliance or non-compliance with EU requirements and report violations, inaccuracies in the instructions for use, or specific infringements.

Even if the product has been on the market for many years without complaints and bears the CE mark, consumers or competitors may raise questions about safety, which may lead to the product being withdrawn from the market. Any negative information about the product or the producing company will lead to increased scrutiny by national authorities in the future.

The manufacturer must ensure that the product meets all agreed requirements to which it is subject and that the testing is complete and not only partial and in accordance with the requirements defined by the standard.

In the European Union, work continues to agree on a new regulation on the safety of consumer products and the repeal of Council Directives 87/357/EEC and 2001/95/EC.

The regulation is intended to be adopted as a law and not as a directive, which means that these requirements are binding in CE states (as opposed to the current General Product Safety Directive).

The Parliament intends to tighten the requirements for product safety and market surveillance rules to strengthen consumer protection. Furthermore, the Parliament wants to increase penalties for companies that sell unsuitable or potentially dangerous products.

A blacklist of companies that have repeatedly violated product safety requirements is proposed.

How do I obtain a CE certificate?

To obtain a CE certificate, you must go through the following steps:

Definition of the directive that regulates this category of goods – At this stage, the requirements of EU legislation for your company's products are examined. If the product cannot be assigned to any of the existing product directives, the General Product Safety Directive (2001/95/EC) applies. It contains general requirements for product safety.

Verification of compliance with the standards of the directive by the company and its products – At this stage, it must also be determined whether there are additional national safety requirements for these products in the country to which the delivery is to be made.

Preparation of technical documentation – The expert visits the company to conduct an audit or analyzes the documentation and production processes remotely in consultation with the client.

Conducting laboratory tests – Laboratory tests confirm compliance with product safety standards and generate a test report.

Certification – Review of the prepared technical documentation by the approval authority. Registration and issuance of a CE certificate.

Marking products with the CE conformity mark – Affixing the CE logo on the product, its packaging, or the accompanying documentation.