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EU 2022 product rules to implement the "blue guide", involving CE certification

SRF 2024-10-14 09:31

On June 29, 2022, the European Union published the newly revised Blue Guide, guidelines for products covered by EU harmonized legislation (I. e. CE-certified products).

Compared with the 2016 edition of the Blue Guide, the new revision in 2022 has not made any major adjustments in the overall framework, and only some chapters and some details have been modified.

1. Placing on the market/putting into use
The 2016 edition of the Blue Guide does not have a clear definition of "self-use. It is generally understood as a scenario in which an employer provides a product or equipment for use by its employees in a form that does not constitute "placing on the market" but is "put into use".
In contrast, the 2022 edition of the Blue Guide has updated the connotation of "self-use, if the manufacturer offers its manufactured products for use by its own employees, these products are provided for use on the EU market and are therefore considered "put on the market" (note that they are not put into use, but put on the market).

This also means that products imported or manufactured by employers for their own use need to comply with EU specific product regulations and require the attention of manufacturers.

2. Online sales and launch
The 2022 edition of the Blue Guide expands the connotation of whether products sold online are considered "put on the market" in the EU.
The guidelines state that an offer of sale is deemed to be directed at an end-user in the EU if the relevant economic practitioner directs its activities to a Member State (products sold online will be deemed to have been "placed on the market" when directed to an EU end-user).

The guidance also notes that the actual fulfillment of an order for a product sold to an EU end-user by an online seller (including a fulfillment service provider) located outside the EU provides clear confirmation that the product has been placed on the EU market, regardless of whether the seller is in or outside the EU.

3. C2C sales in online marketplaces
The 2022 version of the Blue Guide removed the original statement that C2C sales are not usually considered commercial activities.

This means that the products that trigger "put to market" on online platforms and markets include C2C products.

4. About Components
The 2022 edition of the Blue Guide provides further clarification on component requirements.
The guidelines state that a component supplied from its manufacturer and integrated into the final product may constitute placing on the market (meaning that it must be CE-certified) if the component is itself a finished product, or a type of component that is clearly defined by EU product compliance laws.

At the same time, it is also clarified that the manufacturer of the final product can refer to the conformity assessment document of the component manufacturer when conducting the conformity assessment of the final product.

5. Software changes

When the product is qualified, the manufacturer of the final product is obliged to evaluate the possible risks of the software integrated into the product when the product is put on the market., including "network risks" and "risk of loss of connection with the device.

6. About CE marking
For products that need to be assembled, a new explanation is added to the 2022 edition of the Blue Guide: the CE mark should remain visible after assembly, but need not be visible after final installation and normal use.
7. About DoC documentation
Updated Declaration of Conformity (DoC) with new explanation in Blue Guide 2022, emphasize that the DoC is specific to each individual product.

In practice, the same version of the DoC may apply to many individual products manufactured in a series. Once the relevant content of the DoC changes, the DoC version of the product that has been put on the market must be updated for the change.

8. Requirements for instructions and safety information

The 2022 edition of the Blue Guide points out that unless specified by specific legislation, security information still needs to be provided in paper form, and other random information of instructions can be provided in an easily accessible way through websites, electronic labels or two-dimensional codes, which means that random instructions also accept the form of websites, which will greatly reduce the presentation cost of manufacturer's instructions.

Above is introduction of CE Certification by Ancogen Testing Certification, for reference only, some of the material comes from the Internet and does not represent the point of view of Ancor's detection technology and is responsible for its authenticity. If you are involved in the content of the work, copyright and other issues, please contact us within 30 days, we will delete the content in the first time!

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