Prior to exporting, U.S. manufacturers have to consider certification for the EU market.   Certification is about conformity assessment in order to declare compliance with EU regulatory requirements.    For the majority of exported products, compliance is visibly testified by the use of CE marking.    Use of standards is part of the process.    

Bearing in mind that testing and certification for the U.S. market is not enough to export to the EU, manufacturers will need to start from scratch in order to determine what it takes to comply with EU requirements.   Since EU legislation harmonizes mandatory requirements for product safety throughout the European Union, a manufacturer only needs to go through the process once and can then export to all 27 EU member states.   With appropriate certification, goods travel freely within the borders of the Single Market.

Where to start?   That is where we come into the picture:  The Standards Team (Attaché and Specialist) at CSEU offer guidance on the road to regulatory compliance. As a first step, we recommend the websites listed below for an introduction to the range of legislation and standards that may be applicable to your product(s). Contact us for in-depth counseling on EU standards, product testing, and certification requirements.

CE Marking Step-by-Step

1.Read general guidance on standards/labeling/certification in the Country Commercial Guide http://www.buyusa.gov/europeanunion/ccg.html

2. Find the applicable directive (legislation)
http://ec.europa.eu/enterprise/sectors_en.htm

3. Determine the essential requirements in the directive (usually Annex I)

4. Note the harmonized European EN standards
http://www.newapproach.org/Directives/Default.asp

5. Choose the appropriate conformity assessment module as described in the directive’s annex or presented in flow charts in the CE marking guidance booklet – link http://ec.europa.eu/enterprise/newapproach/legislation/guide/document/annex8.pdf

6. Locate Notified Bodies (accredited test laboratories) – if required! http://ec.europa.eu/enterprise/newapproach/nando/

7. Requirement for a Technical File and Declaration of Conformity and apply CE marking http://www.export.gov/cemark/CE_Mark_Declaration.asp
http://ec.europa.eu/enterprise/faq/ce-mark.htm

8. Consider working with consultants
http://www.export.gov/cemark/CE_Consultants.asp http://www.buyusa.gov/europeanunion/services.html 

Frequently Asked Questions:

Where do I find EU product legislation?
Under industry sectors on http://ec.europa.eu/enterprise/sectors_en.htm

If I'm only interested in CE marking legislation, where do I go? http://ec.europa.eu/enterprise/newapproach/legislation/guide/index.htm
http://www.newapproach.org/Directives/Default.asp

Where can I find a list of European standards? http://ec.europa.eu/enterprise/newapproach/standardization/harmstds/whatsnew.html
http://www.newapproach.org/Directives/Default.asp
http://www.cen.eu/catweb/cwen.htm

In the event that I need the services of a test laboratory – EU notified body, U.S. based subcontractor or conformity assessment body -  where do I obtain a list? http://ec.europa.eu/enterprise/newapproach/nando/ http://ts.nist.gov/standards/conformity/mra/valcabs-1200.cfm
http://www.export.gov/cemark/CE_Consultants.asp

Where do I get updates on new developments?

Look under “what’s new” on our website or check the list of market research reports (http://www.buyusa.gov/europeanunion/market_research.html)   

Other Resources

CENELEC, European Committee for Electrotechnical Standardization 
http://www.cenelec.eu/Cenelec/Homepage.htm

ETSI, European Telecommunications Standards Institute http://www.etsi.org/WebSite/homepage.aspx

CEN, European Committee for Standardization
http://www.cen.eu/cenorm/homepage.htm

ANSI, American National Standards Institute http://www.ansi.org/standards_activities/international_programs/critical_issues.aspx?menuid=3

European co-operation for Accreditation
http://www.european-accreditation.org/default_flash.htm

European Union law portal
http://eur-lex.europa.eu/en/index.htm

List of EU New Approach (CE Marking) Directives and Standards http://www.newapproach.org/Directives/Default.asp