The company undertakes the preparation of technical product dossiers for the acquisition of a CE mark. Product certification is a legislative requirement of the European Union for the trade of specific product categories within its borders. The aim of this certification is to ensure the safe operation of products by consumers/users and to reduce their risk in use. Thus, several safety standards and directives have been issued by the European Union leading to the labelling of the product under the CE mark.
The Technical Folder provides information on the design, manufacture and operation of a product and includes all the information required to demonstrate that the product complies with the applicable requirements of the legislation and regulations/instructions.
The services provided by our company, are the following:
- recognition of the required legislation, directives and requirements for products
- preparation of a technical dossier of the product
- the search for appropriate laboratories for carrying out laboratory checks on products – where necessary – and coordination of actions to carry out the checks.
- search and cooperation with a Notified Body for the review of the Technical Documentation and the issue of the Certificate of Conformity (CE Marking).
The CE marking includes products falling within the following New Approach Directives:
- simple pressure vessels
- building materials
- Personal protective equipment (PPE)
- manual scales
- medical devices
- gas combustion appliances
- hot water boilers
- active implantable medical equipment
- interoperability of the trans-European high-speed rail system
- interoperability of the trans-European conventional rail system
- interoperability of the European air traffic management network
- naval equipment
- pressure equipment
- medical diagnostic equipment
- telecommunications terminal equipment
- transportable pressure equipment
- cableway installations
- noise emission to environment by outdoors use equipment
- measuring instruments
- electromagnetic compatibility
- low voltag