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503 482 9289
What Products Require a CE Certificate of Compliance?
A large number of products require licenses in order to be sold in the European Union. It can be frustrating trying to determine what types of international certifications are required. As a certification consultant, we can help get your product up to code and in compliance with international law.
Contact us for CE certificate services if you’re a manufacturer or distributer of any of the below products that are intended to be sold in the European Union:
- electronic products
- telecommunication equipment
- IT equipment
- household appliances
- electromagnetic compatibility products
- equipment and protective systems intended for use in potentially explosive
atmospheres - household refrigerators and freezers
- machinery
- measuring instruments
- personal protective equipment
- radio and telecommunications terminal equipment
- any product that operates on voltage (AA battery, car battery, 110v or 220V,
etc...), including but not limited to household appliances, IT equipment with
no telecom, fitness trackers (ie: Fitbit), hand held power tools, etc...
We specialize in helping gain global market access for products with WIFI, Bluetooth, Cellular and Satellite technology. We also manage items that require separate safety approvals, such as household appliances. When you use CSIA as your CE marking consultant, we can take care of your safety approval as well. Call us today at (503) 482-9289 or Email us with a request for help with international product approval.
CE Certification
For Information on FCC Certifications, CE Mark or International Approvals
Contact CSIA: (503) 482 9289 or e-mail us at quotes@csiassoc.com
For more information on CE Mark watch this video, then contact CSIA.
What Countries Require CE Compliance?
Products that are traded in the European Economic Area must include a mark of European conformity. The EEA includes Austria, Belgium, Bulgaria, Czech Republic, Cyprus, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Liechtenstein, Luxembourg, Malta, Norway, The Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom and Croatia. Although Switzerland is not a member of the European Union, for some products it accepts the CE symbol as a declaration of conformity to Swiss national technical regulations.
What Does CE Certificate of Compliance Mean?
A CE certificate of compliance allows a product to move and be sold freely throughout the European market. This mark provides proof for the consumer that the product meets the environmental, safety and health requirements set by the EEA. A guarantee of compliance is not a quality assurance. It simply means that the product meets the requirements to be sold in the EU.
It’s important to be aware of the fact that a CE stamp does not imply that a product was made in the EEA. A mark of European conformity means that it has been assessed and passed environmental, safety and health requirements that the EEA has set in order for a product to be sold in the EEA.
International Type Approval and Safety Approval
Products that Do Not Require a CE Stamp
To avoid wasting your time searching for a CE testing facility when your product doesn’t require a mark of European conformity, we’ve put together a list of product types that do not require a CE license in order to be sold in the EU.
- chemicals
- pharmaceuticals
- cosmetics
- foodstuffs
What is CE Certification?
CE certification represents the CE mark that is placed on the backside of certain products sold in the European Economic Area (EEA) and the European Union (EU). Literally speaking, CE is an abbreviation of a French phrase that means ‘European Conformity’. When a CE stamp is placed on the backside of a product, this marking signifies that the product is able to be distributed within the EU and the EEA. Read about Brexit and CE Mark here.
The symbol for European conformity consists of a CE mark. The CE stamp is a logo with the letters ‘C’ and ‘E’. Products might also include a four digit id number that represents the process and governing body responsible for the certification.
If you’re interested in finding out more about distribution regulations within the European Union, contact us for information. We’re CE marking consultants, so whether you’re trying to obtain a certificate for your product or you’re searching for a CE testing facility, we can guide you through the process. Call us today at (503) 482-9289 to receive a free quote for our services, or Email us to find out more about compliance regulations.
How Can I Get My Product CE Certified?
Get your CE certificate of compliance with CSIA. We have relationships with testing labs and we can guide manufacturers through the certification process. Here is a brief synopses of the CE Mark testing requirements.
We have helped numerous companies become certified to market their products in the European Union. Our expertise in CE compliance and our international partnerships with testing laboratories, product manufacturers and regulatory agencies makes our company a one-stop-shop for all of your certification needs.
Call us today at (503) 482-9289 to receive a free quote for your product’s global market access, or Email us to find out more about how our CE marking consultants can help you stay in compliance with international law.
Why Is It Important to be in Compliance with CE Standards?
Obtaining a mark of European conformity for products is extremely important for items that are required to meet this level of certification. Although enforcement methods vary, companies may incur penalties for forging CE stamps or disregarding CE compliance. Penalties can include fines, imprisonment, product recalls and product bans.
What is the Responsibility of Manufacturers for Products that Require a CE Stamp?
Product manufacturers that are required to show a CE stamp on their items need to follow a standard process to obtain this certification. The process to obtaining a CE symbol may seem ambiguous. First, manufacturers must carry out a conformity assessment, then they are required to set up a technical file. Next they must issue an EC Declaration of Conformity (DoC). Lastly they must place a CE logo on their product.
If you’re a product manufacturer trying to get your product into the European Union, contact us for help. We’ll provide you with services that guarantee your product will be eligible to sell in the EU.
What is the Responsibility of Distributors for Products that Require a CE Mark?
Distributors of products that require a CE logo must check to make sure the CE stamp is present and properly placed on the item. Distributors also must check supporting documentation to ensure that the CE stamp was legally and properly obtained.
If you’re a product distributor for a product being distributed into the European Economic Area, contact us for professional certification services. We can help make sure your products represent their legal standard of safety, health and environmental protection levels.
Who Sets Standards for Products that are Sold in the EEA?
CE stamp standards are set according to EC Directives. An EC directive is a legal act of the European Union (EU). The EU established regulations for products across many industries in 1985; these regulations included health, safety and environmental standards.
The precedent set for standards and regulation of standards are administered by two separate entities. While the European Union set the standards for CE compliance, regulation of compliance does not have to go through the EU. Instead, compliance may be administered through a variety of methods.
- Each distribution company has the ability to check the compliance efforts of their product manufacturers. In the case that a distributor checks their production client, the manufacturer of the product must present evidence for their CE stamp.
- Different European countries within the European Union have the ability to manage enforcement individually and locally.
- Third party testers can be hired to evaluate whether CE standards have been met.
CE Mark Certification and Self Declaration are both mechanisms used to indicate conformity of products with European Union (EU) regulations, but they differ significantly in terms of process and responsibility:
CE Mark Certification:
Process: Involves a formal assessment by a Notified Body (an organization designated by an EU member state to assess conformity) to ensure the product meets relevant EU directives or regulations.
Responsibility: The manufacturer or importer must submit their product to a Notified Body for assessment. The Notified Body examines the product's design, production methods, and compliance with applicable standards.
Outcome: If the product complies, the Notified Body issues a CE Mark certificate, which the manufacturer can use to demonstrate conformity.
Self Declaration:
Process: The manufacturer or importer declares, on their sole responsibility, that the product meets all applicable EU requirements and affixes the CE Mark accordingly.
Responsibility: The manufacturer or importer assumes full responsibility for ensuring the product's conformity without involvement of a Notified Body.
Outcome: The product can be placed on the EU market with the CE Mark, indicating that the manufacturer has assessed conformity and is compliant with EU regulations.
Key Differences:
Validation: CE Mark Certification involves an external review by a Notified Body, providing a higher level of assurance of conformity compared to Self Declaration, where compliance is determined internally by the manufacturer.
Cost and Time: Certification through a Notified Body can be more costly and time-consuming due to the formal assessment process. Self Declaration, on the other hand, is quicker and more cost-effective but places greater responsibility on the manufacturer.
Complexity: Products with higher risks (e.g., medical devices) generally require CE Mark Certification rather than Self Declaration due to the need for more rigorous assessment and validation.
In summary, while both CE Mark Certification and Self Declaration serve to indicate compliance with EU regulations, the choice between them depends on factors such as product type, risk level, and the manufacturer's resources and capabilities.
Become Certified with CSIA
Whether you’re trying to figure out how to obtain a certification, searching for the right CE testing facility, or interested in getting your product into the European market and you’re not sure how to do it, we can show you how. We are certification consultants, which means we know everything there is to know about the CE compliance industry. Call us today at (503) 482-9289 to receive a free quote for global market access services, or Email us to find out more about CE certificates of compliance.
We specialize in helping companies get the right information about product requirements and regulations in order to legally enter products into international markets. We work with distributors, manufacturers, testing laboratories and regulatory agencies worldwide. We offer resources through information and partnerships between agents. We can help form and build relationships between testing laboratories, manufacturers, distributors and international agencies.
If you’re looking to gain other types of international approval for your product, we can help with that too. CSIA has a global network and we’re able to provide global market access to our clients. We offer international approval, FCC compliance, I/C approval, GMPCS-MoU ITU registration, safety approval, energy efficient certification, VDE certification, translation services, certificate holder service and local representative service. Contact us to find out more about the types of global market access that we can provide for you and your products.
For updates to CE Marking regulations see our CE Marking Updates page.