According to the New Approach Directives of the European Union, products are divided into two groups in terms of risk: low-risk products and high-risk products. High-risk products are products that may pose a risk to their use in terms of human health, life and property safety and environmental conditions. Therefore, conformity assessment of these products must be carried out by a notified body and not by the manufacturer companies. This notified bodyIs an organization that operates in European Union member countries, but has branch or representative offices in other countries.
According to the EU regulations, CE label the high risk ones should be examined by the notified body before they are placed on the market. The notified body is an expert and a third party. They are published in the Official Journal of the European Union and subject to conformity assessment if requested. Notified bodies are organizations that are capable of testing, inspection and certification of the products and whose infrastructure is suitable and sufficient to provide this service. Once these institutions are published in the Official Journal of the European Union, they are granted the status of notified body. In order to gain the status of notified body, it is necessary to first notify the European Commission. Subsequent inspections are carried out by this commission and if it is found in place, the status of the notified body is finalized by the commission.
Notified bodies may be a certification body or an organization or laboratory providing inspection and testing services. With the tests and inspection works to be carried out by these organizations, the conformity of the product with the relevant directives is determined and a report is prepared.
According to the New Approach directives, if a product is in a low-risk group, then the manufacturer does not need to apply to any notified body. Risk analysis and conformity assessment they do their work themselves and put CE marking on the products.
With the publication of the New Approach Directives by the European Union, the candidates for notified bodies from Turkey have been notified to the European Commission. However, the process of adaptation to legal regulations in our country takes time and the process of evaluating the competencies of the candidate organizations has taken a heavy time.
The evaluation process consists of many elements:
- Whether the requirements of the EU Directives are met by published regulations within the scope of harmonization studies
- Whether the candidate body has the necessary audit infrastructure for the application
- Whether the metrology, certification, calibration and similar systems are adequate for the implementation of the application criteria
- Whether the technical infrastructure is adequate and meets the necessary criteria
Notified bodies in our country are subject to the Conformity Assessment Bodies and Notified Bodies Regulation.
The TÜRCERT certification body does not only carry out certification works, but also provides technical services such as various inspection and test work. Therefore, if you want to get more information about the CE marking and the notified body for the CE marking, the experienced managers and employees of the TÜRCERT certification body will always be there for you.