Good day, today with you is Dmytro Grepan from the ECdoc Company., and I will tell you how a Declaration differs from Certification for exporting to the EU.

     Declaration

   The declaration has the full name “Declaration of Conformity,” meaning it asserts that your equipment complies with certain directives (standards). 

   In this case, which is discussed in video, 3 directives are prescribed, as well as a number of certain standards according to which products are tested. What does this mean?

   In Europe, there are approximately 20 directives, each consisting of about 100-150 pages of printed text. They regulate all goods imported into the European Union.

   Your equipment must comply with certain directives, and you declare this compliance. This compliance is based on a technical inspection in accordance with standards, of which there are many. The video shows how each standard is listed line by line over a total of 200 pages. This is a list of just those standards we work with on a regular basis. There are many other standards; for working with these, we turn to our partners to compile the correct set of documents for you.

   Also, the Declaration must necessarily include: the production address; the address and name of the legal entity that exports; the model range (more on this later); the brand; and, also mandatorily, there is a representative in the EU.

     Representative in the EU

   The EU representative is a legal entity that is required to sign your Declaration of Conformity. This is a legislative requirement in the EU. The representative has a contract with you according to which they represent you in the EU territory and are responsible for the technical regulation of your product in this region. 

   The role of the representative involves advocating for your interests and ensuring compliance with technical requirements. They can take on a range of functions, including the withdrawal of the Declaration in case of product non-compliance with requirements, as well as representing you in case of an inspection.

   He is also obligated to provide proper documentation, including the Technical File, which is one of the key elements in the package of documents supporting the Declaration of Conformity. This Technical File contains detailed information about your product and its compliance with the requirements.

   This means that the Declaration of Conformity, signed by the EU representative, is a document certifying that your product meets all the requirements of European legislation. It includes the Instruction and Technical File, which contain detailed information about the product, its properties, specifications, and test results. This package of documents helps protect your interests and ensures the product’s compliance with safety, quality, and environmental standards.

   So, having a faithful representative of the EU and declaratory responsibility, you show your willingness to comply with the rules and regulations of the EU, which contributes to the preservation of consumer confidence and the expansion of export opportunities to the EU country. In the complex of services provided by ECdoc Company processing this step is underway, and we are capable of assisting you in finding this representative.

     Test reports

   Test reports are the protocols of trials that document the results of the tests conducted on a product. They contain detailed information about the trials themselves, including the methodology, conditions, requirements, and the results obtained.

   Test reports are an important part of the product conformity assessment process against established technical standards and requirements. These documents demonstrate that the product has undergone the necessary testing and meets safety, quality, and functionality requirements.

   Test reports often include a detailed description of the conducted tests, collected data, analysis of results, and conclusions regarding the product’s compliance with standard requirements. These documents can be used as proof of product compliance when obtaining a Declaration of Conformity or a Certificate for export to the EU. 

   ECdoc Company intends to assist each of its clients to finally enter the export market, and therefore we are interested in conducting additional test reports if your product requires it. Thus, if during the laboratory research it turns out that the product does not meet certain standards – our ECdoc Company will help you refine your product to the appropriate standard by undergoing additional tests accompanied by consultations with our technical expert.

    Composition

   Layout is a mandatory element of the product conformity assessment process. Layout means using certain nodes or components that have already undergone certification or testing in accordance with the standards’ requirements.

   If you use such certified components in your product, you do not need to retest these specific components. You can simply submit documentation that confirms their compliance as part of your Technical File or Declaration of Conformity. This simplifies the conformity assessment process, as you can focus on those aspects of your product that require separate testing. This strategy allows you to take advantage of the existing certification of parts of the product that have already been verified for compliance with requirements.

     Labeling

  Another mandatory element is labeling. You are required to provide proper labeling on your product that indicates compliance with the standards and directives. This can include the CE marking (Conformité Européenne) or other pictograms that confirm your product’s conformity to established safety, quality, and other standards. Labeling is important from the perspective of identifying the relevant products in the market and ensuring consumer trust in your product. It signifies that the product meets the necessary standards and technical regulation requirements.

       Certificate

   The Certificate (full name Certificate of Conformity) is issued by an independent notified body that, after conducting a conformity assessment against established standards and directives, confirms that your Declaration is justified and authentic. This certificate is evidence of an independent evaluation of your product and its compliance with technical regulation standards. It adds weight to your Declaration and contributes to increasing consumer and market trust in your product.

   It’s important to emphasize that you, as a manufacturer, cannot independently issue a certificate for your own products. This task is for an independent notified body that has the proper accreditation and competence to carry out the product conformity assessment. Your role consists of preparing all the necessary documentation and collaborating with the notified body during the certification process.

   The Company ECdoc has a number of partners – notified bodies in Europe, with whom we work systematically and thus can reduce your time on your own search for this organization, taking into account the fact that in Europe itself, there are “fake” structures that position themselves as accredited bodies, although this is not true. You have to be very careful here, because if an inspection comes to your company, this document, which was issued by a “fake” body, will be considered invalid, which will trigger the imposition of fines and many other unpleasant moments. 

   The Declaration of Conformity is a manufacturer’s constant statement of a product’s compliance with standards and requirements. It does not have a limited validity period and remains valid as long as the product meets the requirements. A certificate is issued for a specific term, usually 5 years, and confirms the product’s conformity with established standards at the time the certificate is issued. This term is limited, and after its expiration, a reassessment and renewal of the certificate may be required.

    It is important to understand that the Certificate is not a guarantee of product safety. The manufacturer remains compliant in all technical aspects of his product, regardless of the presence of the Certificate. If there are questions or problems related to the safety or conformity of the product, the authorities can check the Technical File, where all necessary documentation about the product is stored. The manufacturer must have a properly prepared technical file and ensure compliance of his products with standards and requirements. In turn, it should be said that the Company ECdoc, when providing services, processes the Technical File, Instructions and a number of other important documents of the client, qualitatively and efficiently, so that in the future you will be 100% sure of their reliability and legitimacy.   

   Therefore, the Declaration of Conformity and the Certificate are important elements of product compliance confirmation, but the manufacturer remains responsible for the safety and quality of their product throughout its entire usage period.

      Why exactly do we need a Certificate?

   The certificate plays an important role in the process of proving your product’s compliance with standards and requirements. Here are several reasons why a certificate is important:

Certificate of conformity: The certificate is issued by an independent third party – a notified body that checks your product for compliance with standards and requirements. This provides confidence to consumers, clients, and regulatory bodies that your product meets safety, quality, and efficiency requirements.

• Market expansion: A certificate may be a requirement for entry into certain markets or countries. Some markets or regulatory bodies may require a certificate for the sale or use of a product within their territory. Obtaining a certificate allows you to access new markets and expand your sales opportunities.

• Compliance with regulatory requirements: in some industries, especially those related to safety and health protection, possessing a Certificate may be a mandatory requirement for meeting regulatory standards and demands. This ensures adherence to the rules and reduces the risk of issues or accidents associated with the product.

• Image protection: Obtaining a Certificate confirms your responsibility as a manufacturer and demonstrates your ability to produce products that meet the standards and safety requirements. This positively affects your image and overall consumer trust. 

  The ECdoc company offers a practical approach: 

   If you are a novice exporter and you do not yet have a full understanding of how relevant obtaining a Certificate is for your specific products in the new foreign market, we suggest starting with a Declaration “in hand.” However, keep in mind the potential future transition to obtaining a Certificate, if necessary. 

   Working with the Declaration allows you to quickly bring the product to market and determine its acceptance among consumers. If you encounter difficulties in sales due to the absence of a Certificate, only then obtaining one may be a necessary step.

   The process of obtaining the Certificate includes preparing a package of documents and undergoing an independent audit that confirms your product complies with standards and safety requirements. This process can take approximately 2 weeks and may be costly from a financial standpoint. However, obtaining the Certificate allows you to legally sell your product in various markets, especially in countries where certification is a mandatory requirement.

   The ECdoc company provides services for processing and creating a complete package of documents that will undergo an audit, which ensures an independent verification of all your documentation . This ensures that your product meets established standards and requirements, ensures consumer confidence and expands your business opportunities.

   In general, everything looks like this.

Export from Ukraine.

Product from Ukraine goes to the world!

Sincerely, Dmytro Grepan.

Contact: Company ECdoc