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).
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!
8. Consider working with consultants
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?
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/