Steps to Compliance with CE:

1. You will have to review the directives to determine which apply to your product as well as determine the conformity assessment module(s) applicable for your product.
CITRA offers a directive coverage report that identifies whether or not your product is within the scope of CE marking and which directives apply.

2. Locate European harmonized standards (EN standards) available for your product to address the essential requirements listed in all applicable directives. In some cases, you will find that EN standards have not been developed for your product. If so, you will have to identify other standards to use that effectively address the same concerns.
CITRA maintains a database of all EN standards and can help you identify applicable norms. CITRA is also an authorized standards distributor.

3. You may need to arrange laboratory testing for your product to demonstrate compliance with the essential requirements and standards.
CITRA has established a tight network with qualified test laboratories. You will benefit from CITRA's Project Management by receiving cost-effective testing that meets your specific CE requirements.

4. You may need to hire a Notified Body to review the design, performance and/or manufacturing quality assurance system for your product. The conformity assessment available to you will specify this requirement in detail.
CITRA also works with Notified Bodies on a daily basis. We can help identify those institutions that best match your production and marketing characteristics.

5. You will have to develop a "technical file" in accordance with all applicable directives that documents the application of all directives, essential requirements, standards and other relevant product safety information proving compliance.
CITRA can provide a technical file template and perform reviews of your existing technical file to ensure you have met all requirements.

6. You will have to draft and sign a "declaration of conformity" that identifies the product, the manufacturer and/or the "authorized representative." By signing a "declaration of conformity," you are legally attesting that you have met all CE marking requirements.
CITRA can provide a declaration of conformity template and review your and your suppliers' documents to ensure they are complete and up-to-date.

7. If required, you will have to appoint an "authorized representative" in the EU. An authorized representative is an agent who holds your "technical file" and "declaration of conformity" in the EU for at least 10 years after production of a product has ended. Surveillance authorities may contact your authorized representative if any questions arise about the CE marking compliance of your product.
Benefit from CITRA's connections to European authorized representatives to find the one that is best capable of representing your company.

8. Put the CE mark logo on your products and ship them to Europe!
Download the CE mark logo artwork in various formats from our download section.

Penalties for failing to meet these requirements may include the removal of your products from service, a ban on the importation of your products into the EU, and/or civil and criminal penalties.