Does My Product Need To Comply With CE Certification?
Does my product need to comply with CE certification?
Is CE Certification testing standards compulsory? If a product falls under at least one of the similar directives and there is a related harmonized standard, then yes, the testing standards are compulsory, and products necessary conform to those needs.
Product need to comply with CE certification depends on your product. There are CE Certification instruction and directives for a huge number of product lists. If your product does not fall within the scope of one of this instruction or directives, your product may not bear the CE Marking Certification.
Even if your product does not fall within the scope of CE Marking Certification, the product must always satisfy with the exact product safety needs. These depend on the type of product.
Would you like to know whether your product demands to bear the CE Certification, or which other product safety needs apply? Then contact us. We would be happy to assist.
Does my product need CE Certification?
Many products Need CE Certification before they can be sold in the European Economic Area CE Certification confirm that your product has been fixing and meets European Union safety, health and environmental protection needs. It is valid for products manufactured both inside and outside the European Economic Area, that are then marketed inside the European Economic Area.
CE Certification is most apparently needed if you export to the twenty-seven EU and Three EFTA member states the following 20 list of products:
- Medical Devices
- Hot Water Boilers
- Recreational Craft
- Pressure Equipment
- Construction Products
- Measuring Instruments
- Explosives for Civil Uses
- Simple Pressure Vessels
- Low Voltage Electrical Equipment
- In Vitro Diagnostic Medical Devices
- Active Implantable Medical Devices
- Personal Protective Equipment PPE
- Non-automatic Weighing Instruments
- Cableway Installations to Carry Persons
- Appliances Burning Gaseous Fuels Apply Gas
- Radio Equipment & Telecommunications Terminal Equipment R&TTE
- Equipment and Protective Systems for Used in Potentially Explosive Atmospheres ATEX
Do your products need CE Certification?
Unfortunately, the way of deciding whether the CE Certification applies to a product is a little bit complicated. The European legislator does not give product groups or classification which point out the applicable CE Certification directives.
The CE Certification applies to products sale in the market or put into service in the EEA, and only for convinced product list or product aspects. Thus in order to answer the question of whether a product required to be CE Marked, one has to regulate first in which countries the products are going to be a sale in the market or used. Secondly, for every single directive, it must be fixed whether the products or some of its aspects, fall within its scope.
The CE Certification is needed only in the countries of the EEA. The EEA is formed by the 28 Member States of the EU:
- Czech Republic
- United Kingdom
- The Netherlands
The European Union Declaration of Conformity should contain key information including:
- Name and full address of the manufacturer or his representative
- Name and identification for the notified body, if applicable.
- Product Identification
- List of product safety directive it complies with
- List of harmonized standards or other applied technical standards and specifications
- A statement that the declaration is issued under the sole responsibility of the manufacturer or authorized representative
- Signature of a representative of the organization placing it on the EU/EEA market.
- The date of declaration
Example of a roadmap for CE Certification
What directives and possibly standards apply to your product for CE Certification?
- Perform Conformity Assessment
- Apply safety requirements or risk analysis
- Draw up Technical Construction File
- Draw up a Declaration of Conformity
- Draw up Operating Instructions
- Apply CE Certifications
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