European Standards and CE Marking

Prior to exporting, U.S. manufacturers have to consider certification for the EU market. Certification is about conformity assessment (testing and certification) 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 are not sufficient for exporting 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 the European Economic Area, covering all 28 EU member states + Iceland, Lichtenstein and Norway. 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, Specialist and Assistant) at CSEU offer guidance on the road to regulatory compliance.

As a first step, we recommend consulting 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 interpreting applicable EU legislation (such as testing and certification requirements) and identifying European standards (ENs).

CE Marking Step-by-Step

1. Read general guidance on standards/labeling/certification in the EU Country Commercial Guide

2. Find the applicable piece(s) of legislation

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

4. Note the harmonized European standards (ENs)

5. Choose the appropriate conformity assessment module as described in the directive’s annex or presented in tables in the CE marking guidance booklet “The Blue Guide on the Implementation of EU Product Rules”, beginning on page 119. Depending on the product, self-certification (Module A – internal production) may be an option.

6. Locate Notified Bodies (accredited test laboratories) – if required!

7. Create a Technical File and Declaration of Conformity and apply CE marking

8. Consider working with consultants
http://www.export.gov/cemark/eg_main_017270.asp
http://build.export.gov/europeanunion/businessserviceproviders/index.asp

Frequently Asked Questions:

Where do I find EU product legislation?
Under the relevant industry sector on http://ec.europa.eu/growth/sectors/index_en.htm

Where can I find European standards?

List of harmonized European standards
Catalogue of CEN standards

Catalogue of CENELEC standards

Catalogue of ETSI standards

In the event that the services of a test laboratory – EU notified body, U.S. based subcontractor or conformity assessment body – are required, where to look for a list? http://ec.europa.eu/growth/tools-databases/nando/index.cfm

http://gsi.nist.gov/global/index.cfm/L1-4/L2-16/L3-85/A-90

http://www.export.gov/cemark/eg_main_017270.asp

Other Resources

ANSI, American National Standards Institute
CEN, European Committee for Standardization

CENELEC, European Committee for Electrotechnical Standardization 
ETSI, European Telecommunications Standards Institute
European co-operation for Accreditation
European Union law portal