Self-declaration for CE certification means the manufacturer has assessed the product according to European health, safety, and environmental standards and guarantees the product meets all relevant EC directives and requirements.
The self-declaration process is often quicker
and more cost-effective for manufacturers than working with a certification
body—but not all products can necessarily go the self-declaration route. Read
on to learn more about self-declaration reports.
1. Ensure the CE mark and
self-declaration are appropriate for your product
First things first, make sure your product needs CE certification. There are more than 20 directives governing products sold in the European Union (and non-EU states that use the CE certification system). Many products, but not all, are covered within the scope of these directives.
Products that require CE marking include:
- Food products
- Toys
- Electronics, including all WiFi- and radio-enabled devices
- Personal protective equipment
- Construction products
- Medical devices
- Machinery and industrial equipment
If you determine your product needs the CE
mark, the next step is to determine if self-declaration is a viable option.
Many products can use the self-declaration process, but certain products need
to work with a Notified Body to earn the CE mark.
Products that cannot use the self-declaration process include electrical equipment, high-risk machinery, advanced medical devices, and containers for hazardous materials.
2. Find the appropriate
directive(s)
Once you know that your product needs CE
certification and that self-declaration is a viable option, find the
directive—or group of directives—that applies to your product. All directives
from the European Commission are available on the European Union website, and many requirements
fit within harmonized standards that apply to multiple certification schemes.
An experienced compliance professional can help ensure you identify all
applicable health, safety, and environmental directives and advise you on any
harmonized standards that could be a good long-term investment.
3. Test the product according to
relevant standards
Now that the relevant standards are clear,
test the product according to those requirements. Depending on the situation
and the product, this may involve an external testing agency.
4. Prepare a technical file
The manufacturer of the product must create a technical file with all relevant details about the product and how it performed during testing. The technical file typically includes a list of the standards applied, plus the following items:
- Product description
- Block diagram, wiring diagram, circuit diagram
- Risk assessment and standard assessment records
- List of parts
- Copy of installation instructions, maintenance instructions, and user guide
- Testing reports
- Quality control processes
- Formal declaration of conformity
5. Issue a declaration of
conformity
This is one of the final steps in the process,
and typically the final component of the technical file. The Declaration of
Conformity is a one-page document that asserts the product meets applicable
requirements, signed by the responsible party within the manufacturer’s
company.
6. Affix the CE mark to your
product
When the product has passed testing and the
technical file is complete, it’s time to affix the CE mark to the product. The
CE logo must be affixed to the product itself, the packaging, and/or the
accompanying documents. The European Commission website has detailed requirements for the size and
placement of the CE mark.
Learn More About Self-Declaration for the CE Mark
The compliance professionals at G&M
Compliance can help you determine if your product needs CE certification, and
if so, whether or not the self-declaration process will work for you. G&M
Compliance can support the entire process, from the strategy for harmonized
international standards to the logistics of product testing, and get your
product to market.
Contact G&M Compliance today to get a
quote or learn more about the requirements of the CE Mark.