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European Community Requirements for CE Product Marking What is the CE marking?
All the products we consume every day in the European Union must meet a series of requirements that ensure their quality and safety. The CE marking guarantees that the item has passed the manufacturing, health, design, and environmental protection controls set by European regulations.
The CE marking must be done before marketing the product for the first time in the European Union. It does not necessarily mean that it was manufactured in member countries, but it certifies that it complies with their guidelines. It is mandatory for the product to be marketed in the EU for the first time, regardless of its origin; however, it is not required for all items, only for those for which there are CE marking specifications.
How is the CE product marking obtained?
The manufacturer (or their European representative) is solely responsible for declaring that their product complies with safety regulations and for this reason must obtain the CE Marking.
If you are a manufacturer of products to be sold in the EU, it is best to consult about the CE Marking requirements. To sell your product correctly, it is necessary to be aware of current legislation, so going to a CE specialist company like deviCE Sistemas is the best way to proceed. We are a company specialized in this field with extensive experience and can advise you better than anyone on all the steps you need to follow.
In the case of medical products, before obtaining the CE Marking it is necessary to:
Obtain a prior operating license if you are Spanish.Implement an ISO 13485 Quality Management System.Evaluate the product’s conformity through a notified body or the manufacturer itself, as the case may be.Prepare technical documentation Sign a EU declaration of conformity. Register the product.
Having this documentation is essential as the competent national authority could request it at any time and it must be presented in full.
What is the cost of obtaining the CE marking?
Certainly, the cost varies depending on the product. For those products where the manufacturer can carry out the conformity assessment, that is, those of “self-certification,” the cost is lower than for those products that need to be evaluated by a Notified Body.
Similarly, the cost of advice and consultancy will depend on the product’s complexity, its innovation, the different European standards and laws it must comply with, etc. At deviCE Sistemas we can guide you correctly with a budget tailored to your needs.
Where is the CE marking placed?
Once the CE marking is obtained, it is important to know how and where it should be placed to meet all the requirements:
It must be placed in a location where it can be easily seen, read without difficulty, and where it is not at risk of being damaged. The letters C and E must be the same size and in accordance with the established CE regulations. They can be enlarged or reduced, but always proportionally and according to the established dimensions. The marking must be placed on the product itself. If this is not possible, it must appear visibly on the packaging, and always in the documents accompanying the item.
Going to a consultancy to obtain CE marking will greatly facilitate the management of all the procedures and documentation required for this certification process. At deviCE Sistemas we have extensive experience that we put at the service of our clients to help them throughout the process.
deviCE Sistemas can provide service for any of these roles and has qualified and experienced professionals among its staff who can fulfill these functions.
You can request more information by emailing us at efortea@devicesistemas.com.