In the legislation concerning products, importer is a company in the EU who imports a product from outside the EU to the EU market.
The importer is responsible for ensuring that the products comply with the European requirements and any specific national requirements. If the importer suspects that a product does not comply with the applicable requirements, the importer cannot sell the product in the EU until it has been brought into conformity.
The importer is considered to be the manufacturer if the importer
- places a product on the market under its name or a trademark
- alters a product that has already been placed on the market in a manner that may affect the compliance with the applicable requirements.
What must be done before a product is imported to the EU market?
Before placing a product on the market, the importer must ensure that the product manufacturer has
- performed the conformity assessment procedures required by the legislation applying to the product
- prepared the required technical documentation
- drawn up the EU Declaration of Conformity
- affixed the required markings to the product, such as the CE marking.
The importer must give the following importer information placed on the product:
- registered trade name or registered trademark
If this information cannot be placed on the product, it can be placed on the product packaging or a document included with a product.
In Finland, the importer must ensure that the required documentation, such as operating, installation and maintenance instructions and other required safety information, are included with the product, in Finnish and Swedish. If the manufacturer has not translated the instructions and safety information in Finnish and Swedish, the importer is responsible for translating them.
The importer must ensure that the storage or transport conditions do not jeopardise product compliance.
Obligations after placing the product on the market
The importer must, for 10 years after the product has been placed on the market, keep a copy of the EU Declaration of Conformity available for Tukes. The importer must also ensure that it can make the technical documentation available to Tukes upon request. The importer must co-operate with any competent authority.
The importer must, for 10 years, keep the identifying information of both the companies that have supplied the importer products and the companies to whom the importer has delivered products.
The importer must investigate and, where appropriate, keep a record of any complaints about the products, non-compliant products and product returns. The importer must, where appropriate, take the necessary corrective actions based on the complaints, returns, etc. If the importer in some cases requires the sellers to take actions, the importer must notify the sellers about such cases.
Some directives and decrees require that the importer must carry out sample testing of products already been placed on the market in order to safeguard the health and safety of consumers and other end users as well as the environment. This requirement applies to cases where the tests are deemed appropriate in the light of the risks presented by the products. This requirement applies to certain products that are subject to type examination, such as simple pressure vessels, personal protective equipment and ATEX equipment, and it can also be applied, for example, in cases where the importer has received exceptionally high number of complaints or a high number of non-compliant products has been found in the surveillance operations performed by the market surveillance authorities.
What if the product is non-compliant?
The importer may place only compliant products on the market.
If the importer suspects that a product it has placed on the market does not comply with the applicable requirements, the importer must take immediate action. These actions include, for example
- bringing the product into conformity
- removing the product from the market
- organising a product recall
If the properties of a product present a risk to safety, health or the environment, the importer must inform the market surveillance authority of the non-compliance of the product and of any actions taken by the importer.