Emergo Group: European CE Marking consulting, Authorized Representation & ISO 13485 consulting support. Offices in US, Europe & worldwide. Since 1997.
CE Marking | Authorized Rep | ISO 13485:2003 | About Emergo
www.EmergoGroup.com
CE Mark Testing & Certification. Global Technical & Legal CE Experts
www.cemark-global.com
Full CE Certification complete with DoC & Tech File US$730 in 90% cases
www.barclay-phelps.com
Medical Device Consultants Have Int'l Presence to Assist w/ CE Reqs
www.MDCI.com/ce-mark
We Bring Your Ideas to Market Regulatory Submission & Manufacture
www.accumedix.net
CE / emissions compliance for US boat exports to EU - pre/post sale
www.gablemarine.eu
Provides a forum for industry to develop standards and publications throughout the electronics & high tech industries.
www.eia.org
Committed to advancing industry growth through the development of standards, best practices, accreditations, professional development and more.
www.eidx.org
Emergo Group: European CE Marking consulting, Authorized Representation & ISO 13485 consulting support. Offices in US, Europe & worldwide. Since 1997.
www.EmergoGroup.com
An international membership organization serving industries with a complete portfolio of standards programs.
standards.ieee.org
Certification for ISO 9000, ISO 9000:2000, AS 9000, QS 9000, ISO 14000, EN46000, Training, Consulting, Automation, FDA, CGMP, D1 9000, CE Marking.
www.isoaccel.com
CE Mark Testing & Certification. Global Technical & Legal CE Experts
www.cemark-global.com
Full CE Certification complete with DoC & Tech File US$730 in 90% cases
www.barclay-phelps.com
CE Mark is a term of little import to US domestic businesses. However, for US businesses with an eye toward market involvement in the European Union (EU), CE Mark approval may be the difference between participation and profit, or a closed market. The CE Marking requirement was designed to ensure the health and safety of consumers as well as public interests. Novice US businesses pursuing CE Mark compliance require professional guidance because garnering the CE marking for a product falls under the scope of an EU directive (legislative act) and involves international legal, trade and regulatory knowledge.
Any company looking to obtain a CE Mark must follow certain steps to receive approval. The company needs to complete a market report to determine if the company will benefit from the CE Mark approval process. A CE Mark attorney is needed to handle the process. All products must then pass all CE Marking procedures, which normally covers the design of the product.
1. Conduct market research for the product that needs a CE Marking.
2. Hire a CE Mark attorney.
3. Ensure all products conform to the rigorous CE Marking procedure.
Action Steps
The best contacts and resources to help you get it done
Research the markets the CE mark is targeted toward
Many companies that research foreign markets are available to help. Research into foreign markets give the company a better understanding of the market and the expectant profit of that market. This research narrows down the CE mark requirements you need to abide by.
I recommend: HCI specializes in researching foreign markets and to find the best market for a client's products. Research Insight guarantees that their market research is correct and up-to-date. Subscribe to an online market research company at DemographicsNow.
Locate an attorney with CE mark expertise
Hiring the wrong attorney may cost you more than money. Invest the time necessary to ensure you partner with someone worthy of both your capital and your dreams. Ask questions, including whether or not your attorney delineates his responsibilities to you in writing. Ask how many cases involving CE mark approval he has handled, request the case outcomes and ask for referrals.
I recommend: Weinstein Associates offers more than 20 years of experience and handles many CE marking Companies. Use the American Bar Association's Lawyer Locator to find an attorney by specialty and location. Givens & Johnston, PLLC specializes in import and export laws and marking.
Test all products for CE mark approval
All products listed in the CE mark application must be tested for approval. These tests vary by product.
I recommend: Technology International provides detailed information and regulations for products seeking a CE mark. The Emergo Group tests medical supplies and equipment for CE marking approval. Visit CertifiGroup to find a full range of CE marking services.
Tips & Tactics
Helpful advice for making the most of this Guide
- • Foreign markets change daily. The best option is to choose two or three markets to export to and obtain a CE mark on products for those markets.
Emergo Group: European CE Marking consulting, Authorized Representation & ISO 13485 consulting support. Offices in US, Europe & worldwide. Since 1997.
CE Marking | Authorized Rep | ISO 13485:2003 | About Emergo


