CE Certificate, also known as the CE Mark, is a crucial document that allows a product to circulate freely in the markets established by the European Union and demonstrates whether the product complies with the essential safety and health criteria. The CE Certificate is a conformity document that falls under the New Approach established by the European Union countries in 1985 for products within its scope. Accordingly, for a product to be included in the EU market and be offered for commercial sale, it must fully meet the rules and principles set by accredited organizations for the relevant product. The presence of a CE marking on a product primarily indicates that the product has a conformity certificate when it comes to human and environmental health and poses no issues.

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When a manufacturing company does not obtain a CE mark indicating compliance for its product, it is not possible for that product to be introduced into the European Union (EU) market as stipulated by the relevant regulations. Therefore, a company operating in Turkey and producing a product subject to the required directives under this new approach must obtain a CE Certificate. In this regard, Alkan Patent manages the entire process related to CE Certification and the CE mark, offering top-quality consulting services that cater to all the needs of companies during this process.

The Importance of CE Compliance Certificate

The CE Certificate is a conformity document that allows products to move freely within the boundaries of the European Union (EU). It is crucial for products holding this certificate to meet the criteria specified in the relevant regulations and be presented for sale in compliance with the directives of their respective categories. Derived from the initials of Conformite Europeenne, CE is among the first documents inspected when a product enters the EU countries.

One of the biggest misconceptions about the CE Mark is the belief that it sets a quality standard for a product. However, the CE Mark signifies that a product is safe for human, animal, and environmental health and does not contain any harmful substances. In other words, it demonstrates that the manufacturer offers a guarantee to consumers that the product meets all necessary requirements regarding production methods and material quality, making it a crucial proof of compliance. Companies seeking to obtain the CE Mark can ensure the technical documentation details are prepared by experts by obtaining CE Certification services from accredited organizations specializing in this field.

For a product to obtain a CE Mark, it must follow a specific process correctly. The length and complexity of this process actually vary in proportion to the characteristics of the product. For instance, low-risk products may not require any support from CE Certification companies, whereas high-risk products falling into the category approved by the EU and requiring accreditation should definitely consider contacting CE Certification companies to complete the necessary accreditation process.

For products in the low-risk category, individuals can handle all required testing, analysis, and documentation processes on their own. However, conducting all tests related to CE Certification and preparing the documents specified in the legislation can be time-consuming. If any issues related to the product arise during processes such as distribution, export, sales, and stock management, and additional information is requested by any institution or individual involved in these processes, the manufacturer must promptly provide this information to the relevant party. Therefore, the most critical part of the CE Certification process, which is considered the preparation of the technical file, should be completed and the conformity declaration should be issued before the product is placed on the market. Even if certification services are not sought for this matter, it is advisable to seek assistance from a consultancy firm for the preparation process of this file and all other required procedures.

In contemporary Turkey, the product groups that require a CE Mark can be listed as follows:

  • Elevators,
  • Low voltage electrical equipment groups,
  • Fertilizing products,
  • Pressure equipment,
  • Simple pressure vessels,
  • Entertainment equipment,
  • Actively implantable medical devices,
  • Eco-design devices,
  • Electrical and electronic equipment with limited use of hazardous substances,
  • Devices containing gaseous fuels,
  • Some devices requiring Electromagnetic Compatibility (EMC) compliance,
  • Construction materials,
  • Cableway installations designed to carry persons,
  • Machinery,
  • Personal protective equipment,
  • Toys,
  • Medical devices,
  • Hot water boilers,
  • Radio equipment,
  • Measuring instruments,
  • Non-automatic weighing instruments,
  • Materials with high noise emission levels,
  • Explosives for civil uses,
  • Protective systems and equipment intended for use in potentially explosive atmospheres,
  • Medical devices intended for diagnosis only when used outside the body.

 

Which products are covered by CE Certification and the characteristics of products subject to this system, as well as which materials are exempt from this system, are detailed in the directives published related to the product. Whether your product requires a CE certificate or not can be accurately determined under the scope of Alkan Patent, and you can closely follow all the certification requirements.

How to Obtain a CE Certificate?

If you want to obtain a CE Certificate for a product, the first step is to get information from a consultancy firm specializing in the subject. If you receive consultancy services from a knowledgeable and expert firm in this field, you can ensure the completion of this process as quickly as possible. There are some preparations required for the certification process related to consultancy services. After completing these preparations, you can apply to certification bodies and obtain the CE Certificate.

Here are the basic steps for obtaining a CE certificate:

  • Firstly, you need to contact a consulting firm.
  • Prepare technical file information related to the product.
  • Then, determine the CE directive relevant to the product.
  • Identify the risk category in which the product falls, in accordance with the directive.
  • Research and identify national and international standards related to the product.
  • Understand the required tests, analyses, and technical controls for the product's risk category.
  • Subsequently, obtain support from accredited testing organizations to prepare test reports for the required tests.
  • If there is no existing production documentation for the product, prepare a list including work orders.
  • Create a user manual for the product.
  • Prepare the CE declaration for the product.
  • Compile all necessary documents into a technical file, which must be maintained for at least 10 years, regardless of the type of document.

CE Certification Awaits You with the Difference of Alkan Patent

When it comes to CE Certification, it is now much easier to reach organizations that provide services such as consultancy, training, and certification in this regard. It's important to remember that each of these organizations has different working principles and fee structures. However, it cannot be said that each company has a qualified service approach, taking into account the legal frameworks. Many companies offer CE Certification services without being accredited. It is highly important for companies seeking these services to prefer companies with a qualified and reliable service approach in this regard. Otherwise, undesirable situations such as fines imposed on the manufacturing company and the withdrawal of the product from the market may be inevitable if it is determined that the CE Certificate does not comply with the legal framework. Therefore, it is crucial to always seek support from professional firms that have the necessary legal permissions and work based on experience.

In this sense, Alkan Patent meets your expectations as a company that offers high working standards you are looking for. Its long years of experience and the care it shows to its customers are among the most important features that distinguish Alkan Patent. To experience quality and the peace of mind that comes with working with Alkan Patent, you can contact us immediately using the contact numbers on our website.