Responsible Person requirement for CE-marked products

Responsible Person requirement for CE-marked products

On July 16, 2021, a new EU Regulation on product safety (called the “Market Surveillance Regulation (EU) 2019/1020”) is coming into effect. This new regulation adds the requirement for CE-marked products to have someone present in the European Union acting as the point of contact for product compliance (a “Responsible Person”).

From the regulation:

“1. Notwithstanding any obligations set out in applicable Union harmonisation legislation, a product subject to legislation referred to in paragraph 5 may be placed on the market only if there is an economic operator established in the Union who is responsible for the tasks set out in paragraph 3 in respect of that product.”

This could be “an authorised representative who has a written mandate from the manufacturer designating the authorised representative to perform the tasks set out in paragraph 3 on the manufacturer’s behalf; ”

CTI-CEM are able to act in the capacity of “responsible person” on behalf of the manufacturer in this respect either as part of the product approval process, or for products already certified subject to being provided with satisfactory evidence of compliance of the products to be covered by the responsible person agreement.

If you sell CE-marked products that are manufactured outside of the EU, you will need to ensure that such products have a Responsible Person in the EU prior to July 16, 2021. After July 16, 2021, it will be illegal to sell CE-marked products in the EU without an EU Responsible Person.

Prior to July 16, 2021, you will need to ensure that your CE-marked products are labelled with the contact information of the Responsible Person. This labelling can be done on the product, its packaging, the parcel, or an accompanying document.

From the 16th of July 2021 Amazon will enforce this requirement.

CTI-CEM can act on behalf of customers as the responsible person.

Contact us for more information