Technical File
Refers to the mandatory technical documentation that details the design, manufacture, and operating principles of your product, demonstrates compliance with relevant directives, and covers the product’s entire life cycle.
CE Marking
One of the fundamental requirements of international trade is the verification of product safety and conformity.
- Technical File
- Conformity Assessment
- Access to the EU Market
- Legal Compliance
CE Marking is a fundamental requirement that enables the free movement of your product within the European Union market. This mark is the official proof that your product complies with essential requirements regarding human health, safety, and environmental protection. Preparing an accurate and complete technical file is the key to a successful certification process.
Conformity Assessment
The process of evaluating your product through the application of necessary tests, inspections, and quality assurance systems within the framework of modules determined by the product’s risk level, often involving a notified body.
Access to the EU Market
CE Marking acts as the sole and mandatory “passport” that ensures the free movement and sale of your product within the European Economic Area without encountering any technical barriers.
Legal Compliance
By affixing the CE Mark to the product, the manufacturer declares full responsibility for any damage caused by the product and for any non-compliance with EU legislation, fulfilling all legal obligations.
Frequently Asked Questions
For which products is CE Marking mandatory?
It is mandatory for all products falling under the scope of the “New Approach Directives.”
Is a notified body always required in the CE Marking process?
No; depending on the risk class of the product, a manufacturer’s declaration may suffice, or the intervention of a notified body may be mandatory.
How long should the technical file be kept?
It must be kept for the duration the product is on the market and generally for at least 10 years after production has ceased.
Are CE Marking and quality certification (ISO 9001) the same thing?
No; CE Marking is a legal requirement regarding product safety, while ISO 9001 is a voluntary standard regarding the quality management system.
Is CE Marking valid in countries outside the EU?
It is primarily for the EU market; however, many other countries accept the CE Mark due to similar national regulations.
What is the cost of affixing a CE Mark to a product?
The cost varies depending on the complexity of the product, its risk level, the required tests, and the chosen certification path.
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