CE CERTIFICATION FOR EUROPEAN COUNTRIES

What is CE Certification:

CE Marking (abbreviation from French Conformité Européenne "European conformity") this is a special mark applied to the product, which certifies that the product complies with the basic requirements of the EU directives and the harmonized standards of the European Union, as well as that the product has passed the procedure for assessing compliance with the directives. The CE Marking indicates that the product is not harmful or dangerous to the health of its consumers, as well as harmless to the environment.

However, it should be borne in mind 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 CE Marking (CE Mark).

According to this Decision of the European Parliament, there are recommendations to the countries of the European Union on the control of the EU internal market on the turnover of products subject to mandatory CE Marking. In the countries of the European Community, administrative and criminal penalties have been introduced for violations of the rules relating to the use of CE Marking.

In turn, the CE Certificate is a document that officially confirms the conformity of products with safety standards adopted 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 European Union countries must have CE Marking. The rules for CE Certification and the application of the corresponding CE Marking on products are regulated by Decision N768/2008/EC of the Parliament of the European Union.

The following types of products fall under the action:

  • Children's Toys - Directive 2009/48/EC
  • Building Materials - Directive 305/2011/EC
  • Personal Protective Equipment - Directive 89/686/EC
  • Non-automatic Weighing Devices - Directive 2009/23/EC
  • Low-Voltage Systems, Electrical Safety - Directive 2006/95/EC
  • Laboratory Diagnostic Tools - Directive 98/79/EC
  • Devices for Gaseous Fuels - Directive 2009/142/EC
  • Pressure-Operated Installations - Directive 97/23/EC
  • Electromagnetic Compatibility - Directive 2014/30/EC
  • Simple Pressure Vessels - Directive 2009/105/EC
  • Elevators and Lifting Mechanisms - Directive 95/16/EC
  • Medical Equipment - Directive 2007/47/EC
  • Machinery and Equipment - Directive 2006/42/EC
  • Measuring Instruments - Directive 2004/22/EC
  • New Hot Water Boilers - Directive 92/42/EC
  • Medical Devices - Directive 90/385/EC
  • Radio Communication Equipment - Directive 1999/5/EC
  • Explosives - Directive 93/15/EC
  • Rope Installations - Directive 2000/9/EC
  • Pleasure Craft - Directive 94/25/EC
  • ATEX devices - Directive 94/9/EC

CE Certification Procedure

The manufacturer of the specified products is obliged to make sure that his products are designed and manufactured in accordance with the requirements specified in European standards (harmonized standards) and EU Directives relevant to this product. A certain responsibility for product safety is assigned to distributors and importers, the responsibility is determined by Decision N768/2008/EC.

Harmonized EU standards prescribe the conduct of conformity assessment of products. Conformity assessment is a procedure for certification or verification of products, carried out through modules. Depending on the type of product, the description of the product and its functional features, the present or potential risks, the need for the participation of a third independent party in the conformity assessment, a module is selected for the product conformity procedure.

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 Control of Production and Testing at Intervals - Module A2
  3. Internal Control of Production and Product Testing - Module A1
  4. Sample Research - Module B
  5. Compliance of Samples Based on Internal Control - Module C
  6. Compliance of Samples Based on Controlled Tests - Module C1
  7. Conformity of Samples Based on the Production Process - Module D
  8. Examination of Samples at Time 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. Compliance with the Standard Sample Based on Verification - Module F
  13. Conformity Based on Product Verification - F1 Module
  14. Compliance Based on Unit Verification - Module G
  15. Compliance Based on Full Quality Assurance - Module H
  16. Compliance Based on Design Control - Module H1

When labeling products, additional signs and markings may be applied, such as electrical safety, ATEX, RoHS, fire hazard class, and others. The conditions for applying additional markings are defined by EU Directives. EU States should rely on existing mechanisms to ensure the correct application of the CE Marking regime and take appropriate measures in case of improper application of the CE Marking, should also provide for sanctions for violations, which may include criminal sanctions for serious violations.

These penalties should be proportionate to the gravity of the crime and constitute an effective deterrent against the misuse of the CE Marking. In most cases, the CE Certificate is valid for 3 years with annual inspection control. However, there are certificates issued for 10 years or indefinitely, providing for inspection control only when changes are made to manufactured products.

CE Marking Requirement

The CE Marking mark must be at least 5 mm high. The manufacturer can choose the color and method of applying the marking mark (label, engraving, etc.). The visibility requirement means that the CE Marking should be easily visible. It can be applied on the back or underside of the product. The requirement of visibility does not necessarily mean that the marking should be visible when or before opening the product packaging.

A minimum height of 5 mm is required to ensure its readability. However, according to some legislative acts, the minimum size of the CE Marking may be abolished for small devices or components. The CE Marking must be applied explicitly, clearly, indelibly on the product or on a special product nameplate. However, where this is not possible or justified due to the nature of the products, the marking should be applied to the packaging, if any, or indicated in the accompanying documents.

EU Control over Compliance with the Requirements of CE Standards

EU Member States are obliged to carry out appropriate inspections of products before they are released for free circulation, to withdraw or destroy non-conforming products or to require an authorized representative or manufacturer to take corrective actions to meet the requirements. The control regime 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 system of control over the safety of consumer goods, but also, in accordance with Article 19 (1) of Regulation 765/2008/EC, carry out checks on product characteristics.

This is done both by checking documentation - EU certificates, declarations, test reports and, if necessary, physical and laboratory tests - testing of a product sample. For example, German law requires that regulating the use of one sample per 2,000 inhabitants per year as an indicative target for each federal state. The finances and other resources necessary to achieve this goal must be provided by the German federal budget.

Recently, the frequency of withdrawal of products from circulation, without related security incidents, has increased. The main reasons for such withdrawals are that large retail companies conduct regular compliance testing with the help of accredited laboratories and notified bodies. Customers and, more often, competitors are also becoming more aware of formal issues of compliance or non-compliance with EU requirements and report violations, inaccuracies in user instructions or specific non-compliance.

Even if the product has been on the market for many years without any complaints, and bears the CE Mark, questions may be raised about safety by consumers or competitors, which leads to the risk of removing the product from the market. Any negative information about the product or the manufacturing company leads, in the future, to increased supervision by national authorities.

The manufacturer must be sure that the product meets all the agreed requirements under which it falls and the testing is carried out in full, not in part and in accordance with the requirements that the standard defines. Efforts are continuing within the European Union to agree on a new Regulation on Consumer Product Safety and the repeal of Council Directives 87/357/EEC and 2001/95/EC.

The intention is to adopt the Regulation as a Law, not a Directive, which means that these requirements will be mandatory in the CE States (unlike the current General Security Directive. The purpose of the Parliament is to tighten the requirements for product safety and market surveillance rules in order to strengthen consumer protection. In addition, the parliament wants to tighten penalties for companies selling inappropriate or potentially dangerous products. It is proposed to create a blacklist for companies that have repeatedly violated product safety requirements.

How do I get 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 - During this stage, the requirements of EU legislation for the products of your company are being studied. In the case where the product cannot be attributed to any of the existing Product Directives, the GSPD Directive (2001/95/EC) applies. It contains general requirements for product safety.

Verification of compliance of the company and its products with the standards of the Directive - Also at this stage it is necessary to find out whether there are additional national requirements for the safety of these products in the state where deliveries are planned.

Preparation of technical documentation - The expert travels to the enterprise to conduct an audit, or, in agreement with the client, analyzes the documentation and production processes remotely.

Conducting Laboratory Tests - During laboratory tests, compliance with product safety standards is confirmed and a test report is drawn up.

Certification - Verification of the prepared technical documentation by the licensing authority. Registration and issuance of a CE Certificate.

Marking of Products with the CE Conformity Mark - Application of the CE Logo on the product, its packaging or on the accompanying documentation.

Our Services

We offer the following services to our clients:

  • Consulting on Obtaining CE Certificates of Conformity
  • Development of Technical and Operational Documentation of the CE
  • Preparation of Production for the CE Certification Audit

For more information regarding CE Conformity Certification, please contact us by phone or email.

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