EU Regulation on Market Surveillance and Compliance of Products 2019/1020 applies in the EU from 16 July 2021. 019/1020 replaces the market surveillance provisions in the Regulation and Accreditation Market Surveillance 765/2008 (RAMS).

Overview

Until now, sales where the Business is located outside of the EU and the Customer is in the EU were not regulated. Because there was no legal entity formally responsible for the regulatory compliance of products bought outside the EU.

From July 16th this year, non-EU vendors will have to have an EU authorised representative/economic operator to sell most products to EU customers. The Market Surveillance Regulation lays down rules according to which the fulfilment service provider will be kept responsible when the non-EU vendor doesn’t appoint a responsible person.

Economic Operator

This can be an authorised representative, manufacturer, importer or fulfilment service.

Responsibilities

Keep and provide a Technical File with all the relevant conformity and performance information. Notify risk to the market surveillance authority if it arises. Cooperate with market surveillance authorities requests.

Labelling and contact details

The name and contact details of the responsible economic operator must be indicated on the product or on its packaging, the parcel or an accompanying document.