Dealing With CE Marking Problems & Issues
The CE Marking conformity assessment process and the resulting application of the CE marking shows that a product is compliant with the essential requirements (i.e. Safety, RoHS, etc.) before being placed on the EU market.
In most cases, this process is self-administered by the manufacturer so the manufacturer must produce correct and adequate documentation. In some cases, a Notified Body has to be involved and give certification (i.e. Categories II and III PPE).
The CE marking, which is sometimes mistakenly called a CE Mark, is widely used in Europe to allow products to enter the EU and also move around the market freely without further restrictions. If the marking or the process followed is not correct, products can be held at borders by customs, and it can get expensive for the manufacturer to resolve the issue.
CE Marking is a specialist skill and you should ensure you hire staff who understand the requirements and get it right the first time. Just consider the cumulative effect on the supply chain from products held at customs, not to mention the company’s reputation.
In terms of product safety, there is also the overarching ‘safeguard procedure’ that can stop equipment which the authorities deem to be unsafe from entering the market and also trigger subsequent actions – all potentially expensive to the manufacturer and the supply chain.
Why Do Goods With CE Marking Problems Get Held By Customs?
Here are some of the most common reasons:
1. CE marking missing from the product
2. CE marking used has the incorrect format
3. Cartons and instructions do not appropriately carry the marking
4. Outer packaging not marked
5. Problems with the EU Declarations of Conformity:
- Missing information
- Incorrect and wrong information
- Incorrectly or not signed
- Incorrect standards used
- Format of EU DoC not as it should be
6. Instructions for safe use not adequate or not in the appropriate languages for the intended markets
7. If transparent clamshell packaging is used then marks can be covered up by the pack contents
8. No economic operator identified (Most important from July 2021)
Continue reading to review each in more detail.
Missing CE marking from product
There is a hierarchy for CE Marking as given in Regulation 768/2008 Article R12:
Rules and conditions for affixing the CE marking – The CE marking shall be affixed visibly, legibly and indelibly to the product or to its data plate. Where that is not possible or not warranted on account of the nature of the product, it shall be affixed to the packaging and to the accompanying documents, where the legislation concerned provides for such documents.
So the CE marking should be applied to the product unless it cannot be because of its nature (i.e. it is too small). However, in all cases, we recommend the CE marking is affixed to the product, packaging, and instructions visibly.
Incorrect CE marking format
The format for the CE marking is laid out in the legislation in Regulation 765/2008 Annex II. This gives requirements for the size and shape of the marking. No deviation from this is allowed, for example, a stylized version that may not respect the aspect ratio of the marking.
Cartons, outer packaging, instructions are not properly marked
Customs should be able to look at a product carton and instructions and determine the CE marking status. While it is possible for the product to only carry the marking for completeness, the packaging and documentation should as well.
Problems with the EU DoC
The EU DoC is a legally binding document by the manufacturer stating that the CE Marking conformity assessment process has been correctly completed and the product meets all the requirements.
The EU DoC format requirements are clearly shown in Regulation 768/2008 Annex III as to what it should include and also the legal phrases it must contain. Article R10.3 states that by drawing up the Declaration of Conformity, the manufacturer takes responsibility for the compliance of the product.
The EU DoC should contain all the compliance information for all the directives applicable to the product in a single document.
If the information it contains is incorrect then what conclusions can be drawn about the conformity of the products and the quality aspects?
Problems with the instructions for use
Regulation 768/2008 states under Section 7 of Article R2
Manufacturers shall ensure that the product is accompanied by instructions and safety information in a language which can be easily understood by consumers and other end-users, as determined by the Member State concerned.
The instructions and safety information must be in the language of the intended markets.
For example, a product intended for Germany must have information either in German or in a format that can easily be understood such as pictures and diagrams. Language is very important for safe product use. This could also become a liability issue for the manufacturer in the future if not handled correctly.
Other packaging issues
It’s often fairly easy to mark a cardboard carton. Some products use transparent clamshell packaging for retail purposes. It should be ensured that any compliance markings can be easily viewed through the packaging and not covered in any way by documentation or accessories that are packed with the product. It is recommended to position markings so that they can be viewed with the product still in its packaging,
No economic operator identified
The EU Authorities will require manufacturers and suppliers to have a contact person within the EU in case there are any issues with the product.
Regulation 2019/1020 on Marking and Surveillance requires that an economic operator is clearly identified for the product that is imported to the EU from July 2021. This economic operator needs to be identified for the product and it is expected this will become a basic customs check. The economic operator has certain responsibilities. This closes the loophole where the economic operator could be outside the EU and difficult to contact.
Count On Technology International For Complete CE Marking Services
At Technology International, we’ve been offering CE Marking and compliance support for decades, enabling over 10,000 different types of products and equipment to reach the European market.
If you’re looking for CE Marking and want expert guidance and support to ensure a seamless process in getting your product to market in Europe, click the button below.