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EU Standards and CE Marking
Certification is about conformity assessment in order to declare compliance with EU regulatory requirements, which is visibly testified by the manufacturer through the use of CE marking.

EU Standards

Prior to exporting, U.S. manufacturers must ensure that their products meet applicable EU requirements specified in legislation (Regulations and/or Directives).  Once the required steps are taken, the U.S. manufacturers can normally declare compliance by issuing a Declaration of Conformity and placing a CE mark on the product.  

The conformity assessment activities performed to market a product domestically may not transfer for exporting to the EU. Therefore, manufacturers should carefully review what it takes to comply with EU requirements.

The EU Blue Guide summarizes the general requirements for placing products on the market in the EU.  See Annex IV of this Guide for a chart of manufacturer’s typical conformity assessment steps by module and information on when a conformity assessment body must be used.  

Harmonized Standards (cited in the OJEU) and Presumption of Conformity

In the EU, there are three officially (legally) recognized European Standardization Organizations (ESOs). These produce “harmonized EN (European Norm) standards”. The subset of harmonized standards that are cited in the Official Journal of the European Union (OJEU) are recognized by the European Commission for use by manufacturers in meeting the applicable EU requirements. These OJEU cited harmonized standards can assist manufacturers in designing their products as these standards generally represent the “state-of-the-art.” Products that meet the OJEU cited harmonized standards are presumed (assumed) to meet the applicable EU requirements and provide increased legal certainty for manufacturers. They are said to offer Presumption of Conformity.  

Use of the OJEU cited harmonized standards is not mandatory. Manufacturers have the option to use other standards, but there is then no presumption of conformity. As such, additional conformity assessment requirements may apply, including mandatory use of a Notified Body in some cases.

Notified Bodies 

The product legislation specifies the conditions, if any, for mandatory use of a special type of recognized third-party conformity assessment body called a Notified Body. Depending on the conformity assessment module(s) specified in the legislation, the Notified Bodies’ role and the conformity assessment services they are recognized to offer differs.  

For example: 

  • A Notified Body may be recognized to review the manufacturer’s technical documentation, including test reports (generated by another lab), and issue an EU Type Examination Certificate. This certificate is then included in the manufacturer’s technical documentation that supports their Declaration of Conformity.  
  • A Notified Body may be recognized for product testing required* under specific legislation.  

*Note that most legislation requires product testing as part of the conformity assessment process. The legislation will specify whether the manufacturer has the option to use any lab of its choice (such as their own in-house lab or accredited in-house lab), or whether a third-party lab (or accredited third-party lab), or third-party Notified Body (specifically recognized for testing) must be used.          

Notified Bodies have expertise in the requirements of the applicable legislation and are competent sources for compliance information.  

See Notified Bodies by legislation (by location) to view: (a) the specific legislation and (b) types of conformity assessment services for which the Notified Body has been found competent, select the Notified Body’s link and view the full PDF document(s) posted at the bottom of the page.  

Products Must Meet Current EU Requirements Valid at Time of Placement on the Market  

Generally, EU legislation harmonizes mandatory requirements throughout the 27 member states, so a manufacturer may only need to go through the process once to export the product to the whole region. However, product rules and requirements may change over time meaning that the conditions for placing a product on the market can change. Exporters must make sure that they meet any new/changed requirements valid at the time of placement on the market. As such, manufacturers must monitor the EU regulatory landscape and update the technical documentation and/or Declaration of Conformity as required when the changes occur, even if the same product was commercialized before.  

CE Marking: Suggested First Steps

The European Commission provides general manufacturer guidance and identifies the key steps for CE marking by sector.

CSEU provides a more detailed step of steps below and recommends U.S. manufacturers review the websites listed below for an introduction to the applicable legislation and of legislation and standards: 

  1. Read general guidance on standards/labeling/certification in the EU Country Commercial Guide
  2. Find the applicable legislation
  3. Search for and review any available guidance documents published by the European Commission that might apply to the legislation in question.
  4. Determine the requirements in the legislation (Essential Requirements are usually Annex I)
  5. Identify the Harmonized Standards cited in the OJEU for presumption of conformity,  or select other standards to be used
  6. Choose the appropriate conformity assessment module as described in the legislation’s Annexes and follow the required steps. 
  7. Locate Notified Bodies to obtain an EU Type Examination Certification if required.
  8. Test Product (use appropriately qualified test lab and/or Notified Body if required)
  9. Assemble the Technical Documentation, prepare the Declaration of Conformity and apply CE marking

Many U.S. companies contact our office or retain a consultant to help them through this process.

Frequently Asked Questions

Q: Where do I find EU product legislation?
A: Under industry sectors on the European Commission website.

Q: Where can I find European (EN) standards? 
A: Search for standards on these sites: 

Q: If I need the services of an EU Notified Body, where can I find one? 
A: Please consult the following resources: 

Q: If I need the services of a product testing lab, where can I find one? 
A: First, determine the qualifications of the test lab specified by the applicable legislation.  If a Notified Body must do the testing, go to the link above.  Otherwise, see some suggested resources below: 

Other Resources