The person who places the item on the European single market can produce and sign the Declaration of Conformity. In most circumstances, this person is the maker or importer of the product.
When importing a product from a non-EU country into the EU/EEA, the importers must mean that the product meets all applicable product safety criteria. Furthermore, the importer is responsible for ensuring that the technical file is correctly built and accessible.
Distributors are not required to create the DoC but must ensure that the manufacturer or importer has undertaken all legally mandated precautions. On the other hand, if a distributor decides to rename or change a product, they must assume the manufacturer’s obligations. Thus, draw up and sign a Declaration of Conformity.
The manufacturer’s EU can alternatively sign the DoC authorized representative. The authorized representative must be based in the EU/EEA and specifically appointed by the manufacturer in the non-EU nation.
The EU Declaration of Conformity (DoC) is a legal document in which a manufacturer officially proclaims a product’s compliance with the relevant directives’ key health, safety, and environmental protections. The manufacturer bears full responsibility for the CE conformity of the product by preparing and signing the EU Declaration of Conformity. The DoC is created only when the technical documentation (also known as the technical file) has been compiled.
The Declaration of Conformity is required for any product subject to CE marking legislation. When multiple product safety directives protect a product, just a single DoC is necessary for most circumstances.
A copy of the Declaration of Conformity shall be kept in the technical file and accessible to national market surveillance agencies upon request. If the Declaration is unavailable or invalid, market authorities will return the product levy a monetary fee, and the individual who placed the product on the market may face incarceration.
Unless otherwise specified in the relevant CE regulations, the Declaration of Conformity shall be preserved for ten years from the date of placing the final product on the market.
The DoC must be written in one of the European Union’s official languages. However, the CE guidelines do not always indicate who is required to translate it. Logically, this should be responsible for bringing the goods to the EU single market.
Most CE directives and regulations have varying criteria for the Declaration of Conformity content. The format and scope of the Declaration of Conformity, on the other hand, should adhere to a “model structure” to make it easier to interpret, especially if it is written in a different language or alphabet. The following elements are typically included in the DoC:
The product manufacturer’s or authorized representative’s name and business address.
Identification that allows the product to be traced. A serial or model number, for example, or type identifier
If applicable, body information was communicated.
A declaration stating that the maker is solely responsible for the product’s compliance.
A list of all CE directives and rules with which the product conforms
A list of all EN harmonized standards or procedures used to ensure that the product complies with the directives.
Manufacturer’s name and signature
The location and date of the DoC’s issuance
Please provide any more details
Both the terms EU and EC are used. You are accurate. EU stands for European Union. Union and EC are abbreviations for the European Commission. There are no CE certificates of compliance.
If a product falls inside the purview of at least one of the following product groupings, it must have a Declaration of Conformity:
Installations of lifts and cableways
Building materials
Radio equipment Electrical equipment Energy-related products
Explosive atmospheres require special equipment.
Explosives
Articles on pyrotechnics
Gasoline appliances
Machinery
Weighing equipment
Instruments for measuring
In-vitro medical devices and medical equipment
Medical implants are implantable devices.
Outdoor noise-emitting apparatus
Personal safety equipment (PPE)
Pressure vessels and pressure equipment
Hazardous substance-containing products
Toys for recreation
Boilers for water
The four procedures outlined below should assist anyone with CE marking experience in drafting their Declaration of Conformity:
On the European Commission’s website, choose an appropriate product group.
Read about the Declaration of Conformity in the relevant Directive’s content.
Create the DoC.
Check to see if the Declaration of Conformity you created fits all the requirements.
However, if the individual has never worked with the CE certification process, there is a great danger of making mistakes. As a result, importers and producers with no prior experience with CE marking can benefit from our doc creation tool, Declaration of Conformity Generator.
Common omissions found in Declarations
Although the Declaration of Conformity’s appearance is rather simple, it is easy to make a mistake in the details of its content. A single inaccuracy can render the Declaration of Conformity null and void. The following is a list of some of the most common errors identified in DoCs:
Instead of a statement, the title of the document is a certificate.
It says ‘CE declaration’ rather than ‘EU declaration.’
A collection of all important standards and directives that is not exhaustive.
There is no signature.
A statement of conformance is missing from the DoC.
The person signing the DoC is not employed or holds a suitable position inside the organization.
Some of the indicated standards or directives were issued before the release date.
The Declaration of Conformity is deceptive or confusing (e.g. it contains a list of irrelevant standards)
The product has a serial number; however, it is not mentioned in the DoC.
Not that all standards have the necessary prefixes and numbers.
All products offered by Amazon’s third-party sellers must meet product safety regulations and labeling laws in each marketplace. As a result, to sell on Amazon’s European marketplaces, goods that need CE marking in the European Union must be CE marked.
Amazon does not require CE marking for products that do not fall under the purview of one of the “CE marking directives.” Here are a couple of such examples:
EMC Directive
Low Voltage Directive
RoHS Directive
Radio Equipment Directive
Toy Safety Directive
Personal Protective Equipment (PPE) Directive
Medical Devices Directive
As previously stated, products that fall under the purview of one or more “CE marking directives” must have the CE mark. Here are several examples:
Electronics for the home
Toys
Helmets
Sunglasses
Machines
The whole product list may be seen here.
CE certification is required in all EU nations. As a result, CE marking is necessary when selling specific products on any of Amazon’s European marketplaces:
www.amazon.de
www.amazon.it
www.amazon.fr
www.amazon.se
CE labeling is necessary on Amazon.co.uk, at least for the time being. That is likely to alter in the coming years.
CE compliance entails far more than simply placing a CE mark on a product. To support the CE mark, you must obtain or provide the following documents:
Reports from laboratory tests
Technical file for Declaration of Conformity
Instructions for use
These are also the paperwork that Amazon requests and reviews to determine whether or not your product is CE compliant. An example of a CE compliance document check from Amazon is provided below.
As you can see in the preceding example, Amazon provides merchants 14 days to reply to a compliance documentation request. If you do not comply, they will limit your ability to sell the goods and delist.
A new EU Regulation on product safety (the ‘Market Surveillance Regulation (EU) 2019/1020’) goes into force on July 16, 2021. This new rule requires CE-marked items to have a person in the room in the European Union functioning as the contact point for product compliance (a ‘Responsible Person’).
This page explains what is changing and provides advice on preparing for the changes. This information is provided solely for educational reasons. It is not meant to provide legal advice. If you have any queries about the rules and regulations that apply to your products, we recommend that you speak with your legal counsel.
If you sell CE-marked items made outside the EU, you must verify that such products have a Responsible Person in the EU by July 16, 2021. It will be illegal to trade CE-marked products in the EU without the need for an EU Responsible Person after July 16, 2021.
Your CE-marked products must be labeled with the Responsible Person’s contact details. This labeling might be done on the goods, their container, the delivery, or the documentation that comes with it.
A European Union Responsible Person can be any of the following:
If the maker or brand is based in the EU
An importer with a presence in the European Union
An official representative based in the EU has been designated as the Responsible Person in writing by the manufacturer or brand.
A fulfillment service company based in the European Union
The Responsible Person must collect the product’s EU Declaration of Conformance (or Declaration of Performance) and ensure that other documentation confirming EU conformity of the product are accessible upon demand from the manufacturer or brand owner in a language recognized by an authority;
Inform authorities of any risks posed by the product in particular situations; and
Cooperate with market surveillance authorities, including ensuring that the producer or brand owner takes the appropriate corrective actions to resolve any product non-compliance.
Furthermore, the Responsible Person’s contact information must be displayed on the goods or their packaging, the shipment, or an accompanying document.