CE certification is not recognized in the USA.
CE certification is a mandatory conformity mark for the European Union (EU) market, indicating that a product meets EU regULations regarding health, safety, and environmental protection. The USA, however, has its own independent certification systems, such as:
Federal Communications Commission (FCC) certification
Underwriters Laboratories (UL) certification
Food and Drug Administration (FDA) certification
These certifications are specific to different product categories and serve as the basis for market entry in the US. CE certification and US certifications are not interchangeable. To export products to the USA, manufacturers must obtain the relevant US certifications according to product type and US regulations.
The EU mandates the use of the CE mark on many products, including:
1. Electronics
2. Toys
3. Medical devices
4. Personal protective equipment (PPE)
Some non-EU countries, including Turkey and the UK, accept certain products with CE marking. Additionally, other countries/regions recognize specific aspects of CE marking, such as EN standards.
After Brexit, the UK requires the ukca (UK Conformity Assessed) markto indicate compliance with regulations that previously requiRED the CE mark.
① Until December 31, 2024, importers and manufacturers may use either CE or UKCA marks when placing products on the UK market.
② The UK government plans legislation to indefinitely recognize the CE mark after December 31, 2024.
Products eligible for CE marking in the UK include:
1. Electrical and electronic products, including radio equipment
2. Toys
3. PPE
4. Machinery
5. Marine equipment
6. Simple pressure vessels
7. Non-automatic weighing instruments
8. Measuring instruments
9. Measuring containers and bottles
10. Fireworks
11. Lifts
12. Equipment for potentially explosive environments (UKEX)
13. Pressure equipment
14. Gas appliances
Although Turkey is not an EU member, it enforces CE marking for products under the CE Marking Regulation. Manufacturers and importers must:
1. Comply with relevant European “harmonized standards”
2. Prepare technical documentation
3. Conduct conformity assessment procedures
4. Issue a Declaration of Conformity (DoC)
5. Affix the CE mark and label on the product
6. Retain technical documentation and DoC for the prescribed period
Switzerland has a Mutual Recognition Agreement (MRA)with the EU covering certain product categories, including:
1. Machinery
2. Medical devices
3. Electrical equipment
4. Construction products
5. Lifts
6. Biocidal products
For MRA-covered products, a single conformity assessment by a recognized body under EU or Swiss regulations allows market entry into both regions. CE marks can substitute Swiss conformity marks where applicable (e.g., for radio equipment). Products not covered by MRA must comply with Swiss-specific regulations.
Norway is an EFTA member, so it follows CE marking requirements. Companies importing or manufacturing CE-marked products in Norway must comply with relevant EU requirements.
Iceland, also an EFTA member, requires products covered by CE directives or regulations to comply with CE marking requirements.
As an EFTA member, Liechtenstein mandates compliance with all relevant CE marking regulations before placing products on the market.
Israel has an MRA with the EUto facilitate trade and market access. Qualified assessment results from EU or Israeli designated bodies (CAB) are recognized. Covered products include:
1. TV broadcast receivers
2. Cosmetics
3. Industrial cheMICals
4. Pharmaceuticals
5. Food additives
Israel has issued Radio Regulations Amendment 5722-2022, allowing CE-related test reports and documentation (e.g., technical files, DoC) to be used for Israeli type certification.
As an EU candidate country, North Macedonia aligns its technical regulations with EU standards. CE marking is required for products to demonstrate compliance with:
1. Electrical safety
2. Electromagnetic compatibility (EMC)
3. Energy efficiency
Serbia, while not an EU member, adopts many EU regulations. CE marking is required for specific product categories, including:
1. Electrical appliances
2. Toys
3. Machinery
4. PPE
5. Pressure equipment
6. Lifts
7. Measuring instruments
This ensures compliance with relevant CE marking directives and regulations.
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