Thought Leadership - The Transatlantic Advantage: Expanding American Business into Europe

The Transatlantic Advantage: Expanding American Business into Europe

How to Navigate CE Compliance and enter the European Market Smoothly
Every day, more than $6.4 billion worth of goods and services are traded between Europe and the United States (Source: AmCham EU)
For decades, European consumers have had a strong affinity for American brands and products—the ideal conditions for sustainable growth in the European market. Yet although Europe is already one of the most important and largest markets for American exporters, only a small fraction of all U.S. companies export internationally at all.
One obstacle to exporting to Europe is the “regulatory standards” that an American product must meet to be sold on the European market.
While UL certification is essential for European companies exporting to the US, CE conformity is equally essential for American companies selling on the European Market.
 
What you need to know about CE
The CE marking
By affixing the CE marking to a product, a manufacturer declares that the product meets all the legal requirements for CE marking and can be sold throughout the European Economic Area (EEA). They signify that products sold in the EEA have been assessed to meet high safety, health, and environmental protection requirements.
 
Benefits of a CE Marking
Businesses know that products bearing the CE marking can be traded in the EEA without restrictions
Consumers enjoy the same level of health, safety, and environmental protection throughout the entire EEA
Fairness: CE marking also supports fair competition by holding all companies accountable to the same rules.
You can download the CE Mark here:
https://single-market-economy.ec.europa.eu/single-market/goods/ce-marking_en?
 
Which products must have a CE marking?
The affixing of the CE mark is not voluntary. Every manufacturer, importer, or distributor must determine for each product whether there is a marking requirement and what obligations or risks this entails for them. CE marking is compulsory for products covered by the “New Approach” Directives. For example:

• Electronics and household appliances
• Toys
• Machinery
• Medical devices
• Radio equipment/Wi-Fi/Bluetooth devices
• Personal protective equipment (e.g., helmets, safety goggles)
• Construction products (some of which are subject to additional regulations)

Whether your product is affected, the list of directives and standards can be found on the website
https://single-market-economy.ec.europa.eu/single-market/goods/ce-marking_en?
 
CE verus UL

CE	UL
Mandatory labeling for many products in the EU	Safety certification from the U.S.
Mandatory mark for certain product groups	Mostly voluntary, but often required by the market
Manufacturer self-declares conformity	Independent testing organization tests the product
Focus: EU directives and overall conformity	Focus: Product safety, particularly electrical/fire hazards
Applies to the European market	Primarily relevant in the US and Canada

 
In the table you can see one of the main differences between UL and CE is that for UL the product is tested before the UL is granted – CE is applied by the manufacturer who simply states that the product complies to the CE regulations. That doesn’t mean that the CE Mark can be applied to your product without testing, though. If anything happens, the manufacturer must prove that any potential defects have been identified, investigated, analyzed, and corrected and documented so that the product complies with safety, health, and environmental protection requirements.
Here is what you need to do:

10 Steps to Successful CE Marking

1. Intended Use
   Together, we determine the intended use of your product and the groups of people who will eventually use it.

2. Identifying CE Directives
   We identify the relevant CE directives for your product and the implications thereof. Furthermore, we determine any additional requirements or specific options in the country of use (so-called “transposition into national law”).
3. Researching harmonized standards
   We determine whether so-called harmonized standards exist that are applicable to your product.
4. Requirements and conditions
   We clarify which specific requirements and conditions are derived from the standards for your product.
5. Notified Body
   In this step, we determine whether a “Notified Body,” such as a testing laboratory or another authorized third party, must be involved in the conformity assessment procedure.
6. Conformity Assessment Procedure
   Through a hazard analysis or risk assessment, we identify the hazard categories relevant to your product, their consequences, the sources of the hazards, and the locations where they occur. We define the necessary protective measures and evaluate whether the risk is sufficiently eliminated or minimized.
7. Technical Documentation
   We prepare the technical documentation for your product in accordance with EU requirements, including operating instructions, user manual, assembly instructions (if applicable), EC type examination certificate, circuit diagram, etc. We also provide the necessary translations for countries where the product is intended for use.
8. EU Declaration of Conformity
   We prepare the Declaration of Conformity, which you, as the manufacturer or distributor, simply need to sign.
9. CE Marking
   You may now affix the CE mark to your product, including the identification number of the Notified Body (if required), e.g., as a print on the nameplate.
10. Compliance with Legal Requirements and the Current State of the Art
    Due to previously unknown or unrecognized risks, re-inspections, corrections, and new certifications may become necessary for your product. Upon request, we regularly monitor whether there are changes to the standards and directives relevant to you and how the state of the art is evolving.

 
Where tech-solute can help:
tech-solute USA Inc. offers a range of services for US companies wishing to enter the EU Market. Our Colleagues in our headquarters in Germany are experts for the European Market and have been designing products and ensuring CE conformity for over 24 years.

• For companies with a finished product that requires CE conformity, we can organize all the necessary steps. If the risk assessment results in a necessary re-design of a part of the product, we figure out what needs to be changed in close coordination with you and go ahead and complete the CE conformity successfully.

 

• For companies that are not sure about whether their product could be successful in the European Market we can assist with
  • Market research
    • Target group
    • Comparable products (Benchmarking), local requirements
    • Pricing (inkl. VAT)
  • DSGVO compliance
  • Finding suppliers and manufacturing partners if neccessary
  • Engineering
    • Designing / Re-Designing your product to fit the preferences and requirements of the European Market
    • Innovation ideas
    • Patent applications
    • Quality assurance. FMEA, FTA, etc.
  • An honest opinion on the chances we see for your product in the European Market based on experience and researched facts with a recommendation whether to “go for it” or not.

 
 
About tech-solute
tech-solute brings German engineering precision to American innovation challenges. Founded in 2002 and based in Bruchsal, Germany, we're now expanding across the United States to serve end-to-end product development for companies seeking technical innovation at pace or wishing to successfully launch their products on the European market. Contact John Abramov for more information and a free 60 minute “ask-me-anything” session so you can meet us and find out more about the EU Market and CE regulations. John.abramov@tech-solute-USA.com
 
 
For all companies not quite sure about whether to take this step or not, there are many good reasons to consider. Give it a think:
7 Good Reasons to Export to Europe

1. The European Union and the United States have the largest bilateral trade and investment relationship and the most integrated economic relationship in the world. (European Council: https://www.consilium.europa.eu/en/infographics/eu-us-trade/)
2. Europe offers access to over 450 million consumers
   By entering the EU market, companies can reach numerous countries through a single common market.
3. Demand for U.S. products is already well-established
   Pharmaceuticals, machinery, technology, and energy products are in particularly high demand
4. The U.S. is Europe’s most important trading partner.
5. American brands enjoy a high level of trust in many industries.
   Especially in the fields of technology, lifestyle, software, medicine, food & beverage, and premium consumer goods, U.S. brands are regarded in Europe as innovative and high-quality
6. Diversification reduces dependence on the U.S. domestic market..
   Exporting to Europe opens up additional revenue streams and reduces the risk of relying exclusively on the U.S. market.
7. Stable infrastructure and regulatory certainty.
   Europe offers a high degree of legal certainty, modern logistics networks, and a transparent single market—key factors for long-term international growth.

 
If you have any questions, feel free to contact us contact@tech-solute-USA.com
 
 
Sources:
https://transatlantic.amchameu.eu
https://single-market-economy.ec.europa.eu/single-market/goods/ce-marking_en?
https://www.trade.gov/feature-article/introducing-itas-exporter-database