From 16 July 2021, any CE-marked products that are sold into the EU, will have to have an EU established economic operator listed on the product or packaging. The economic operator can be a manufacturer, importer, authorized representative or fulfilment service provider based in the EU.
This is due to the new EU regulations on market surveillance together with the Guidelines for its practical implementation. To ensure you're compliant with the new regulations, follow these steps:
- Check if you are selling CE marked products into the EU. You can see examples of products that carry the CE mark in our FAQ.
- Verify the products are meant for the EU market and comply with the EU legislation. If in doubt, contact the manufacturer.
- If the products are compliant, check whether you see information of the EU manufacturer or EU importer on the products. If there is an EU manufacturer or importer, they are the economic operator in Europe.
- If there is no EU manufacturer or importer, check with the non-EU manufacturer to see if they have an authorized representative. If there is one, obtain the name and contact details (including postal address) of the authorized representative and ensure that the information is indicated on the product or its packaging.
- If the non-EU manufacturer has not appointed an authorized representative in the EU, work with the manufacturer to appoint one. The authorized representative will need a mandate signed by the manufacturer as well as obtaining and keeping the certificate of conformity/performance and other technical documentation from the manufacturer
- Alternatively, you can use a fulfilment service provider in the EU — if you do not currently have an economic operator and you’re looking for an EU-authorised representative for the compliant products, some experienced third-party companies were identified for your assistance.
If you can't appoint or obtain information of an economic operator for the CE marked products you intend to sell to the EU on or before 16 July 2021, you will not be allowed to sell the product to the EU until an economic operator in the EU is arranged for.