CE CERTIFICATE
The CE Certificate marking shape must be as follows, even if the dimensions change, the proportions must be respected. The CE Certificate marking must be affixed on the product information plate / label in a visible, legible, indelible manner. If these conditions cannot be met due to reasons arising from the nature of the product, it must be attached to the product packaging or appropriate documents.
CE CERTIFICATE BASIC REQUIREMENTS
The common denominator of the European Union regulations is that the products to bear the CE Certificate marking are determined by the basic requirements that set out the high health and safety requirements. Basic requirements refer to the design and software hazards in the structure of the product, so manufacturers should conduct risk analyses according to the relevant general standard and include them in their technical dossiers, unless the type C harmonized standards they use are included.
WHAT SHOULD CE CERTIFICATE TECHNICAL FILE (TECHNICAL DOCUMENTATION) CONTAIN?
European Union regulations oblige manufacturers to prepare a technical file containing information to prove that their products comply with the essential requirements and to keep this file for 10 years.
Although the requirements of the technical file are specified in detail in each regulation, it generally includes information and documents related to product description, intended use, design, production, manufacturing management.
CE CERTIFICATE APPROVED ORGANIZATIONS
The notified body carries out the testing, inspection, inspection and certification activities specified in the conformity assessment instructions in cases requiring third party type approval according to the regulation. Notified bodies are appointed by authorized accredited European Union accreditation bodies in accordance with the principles set out in the relevant regulation and notified to the EU Commission.
WHY SHOULD ACCREDITATION BE PREFERRED?
Accreditation is the approval by the national accreditation body that the conformity assessment body has the technical competence to carry out the relevant conformity assessment activities under the conditions specified in the standards. With the directive 765/2008, the legal framework of the accreditation requirement in the EU has been determined. Accreditation is an important factor in terms of determining product conformity by carrying out conformity assessment activities in a healthy way and trusting the CE Certification activities of the conformity assessment body.