EU Changes Requirements to Market Surveillance and Compliance of Products

20 October 2020

New EU Regulations on market surveillance and compliance of products that amends Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011 will come into force in 2021.

The Regulation is developed to guarantee that products placed on the EU market are in compliance with the EU harmonization legislation. It means that such products are absolutely safe for consumers.

With the development of new technologies, it becomes possible to sell goods using e-commerce. The new Regulations are aimed at strengthening market surveillance to protect customers' rights and apply not only to the physical marketplaces but to the internet market as well. It covers non-food products and includes 70 Regulations and Directives, such as medical devices, toys and children’s products, softlines units, etc.

When referring to the e-commerce sector, you should take into consideration the following requirements:

Once a product is going to be sold on any of the EU member state markets it is subject to the market surveillance procedure no matter whether it is sold online or physically placed on the EU market.

It is necessary to have an EU authorized representative in case the importer/manufacturer is not an EU member. According to the Regulation, if there is no such EU representative, his functions lay upon a fulfillment service provider established in the Union for products handled by it.

Thus, an EU economic operator can be not only an EU manufacturer or importer but an EU authorized representative or at least an EU fulfillment service provider.

According to the Regulations, now the EU economic operator has the following tasks:

Keep technical documentation on the product and EU declaration (if any)

Provide information and documentation that shows the conformity of the product EU regulations on request. Moreover, all these documents must be in the national language of that state where the product is going to be sold

If the product constitutes a danger to the consumer, the economic operator must notify the market surveillance authorities thereof

The new Regulation also gives an important role to the Union Product Compliance Network (the ‘Network’) that becomes a platform for coordination and cooperation between authorities of the Member States and the Commission. Moreover, it allows speeding up the market surveillance procedure within the EU.

The Regulations itself will become effective from July 16, 2021. However, provisions on the Network will come into force from January 1, 2021.