This new regulation will affect all companies that sell CE-marked products manufactured outside the European Union.
As the Brexit transition period is over, this includes UK-made products, but also e-commerce and e-business companies like Amazon. Therefore, resellers of CE-marked products should make sure that their suppliers have made the necessary arrangements for the designated agent.
As of July 16, 2021, the new regulation 2019/1020 / EU (Market surveillance and product compliance) will come into force. US FDA Consultants After this date, CE-marked products cannot be sold in Europe without an authorized representative based in the EU.
Please note that medical devices, cableway facilities, civilian explosives, kettles, and elevators are not affected by this new standard.
Who to choose?
- An authorized representative in the EU can be:
- The manufacturer or brand
- The importer
- An authorized representative designated by the manufacturer
- This person must be established in the European Union.
What are your obligations?
Before July 16, 2021, the affected companies must ensure that their CE-marked products continue to meet quality and safety standards and that they carry the contact details of the authorized representative.
This labeling can be done on the product, on its packaging, or in an accompanying document.
They will have to collect the declaration of conformity and ensure that additional documents are available upon request from the authorities.
In certain cases, you will also have to alert the authorities to the risks posed by the products, cooperate with the authorities in market surveillance, and ensure that the manufacturer takes the necessary steps to remedy the non-conformity of the product.
After the deadline, it will be illegal to sell CE-marked products in the EU without a designated representative established in the area and without a proper label.
CE marking: a European quality guarantee
The CE marking has been created within the framework of European technical harmonization legislation. By affixing the CE marking to its products, a manufacturer declares that its products comply with European legal standards and can be sold in the European Union.
You take responsibility for complying with all European health, safety, performance, and environmental protection requirements that apply to your product.
“CE” stands for “European Conformity“. Therefore, it is not a certification mark or an indication of the geographical origin of the product.
The CE marking must be visible, legible, and indelible. There are many categories of products that can carry the CE marking: they can be machines, toys, or televisions.
The absence of marking or “false marking” can be sanctioned through administrative and criminal procedures.
Do you want to know more about European regulations? Visit https://www.reghelps.com/