EU Changes the requirements for Market Compliance

EU Changes the requirements for Market Compliance
May 04, 2021

New EU Regulations on market monitoring 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 In order to promise products are safe for consumers. It covers non-food products and includes 70 Regulations and Directives, such as medical devices, toys and children’s products, soft lines units, etc. Regarding the e-commerce sector, you should know the following requirements:

1.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.

2.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.

According to that, 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. Now the EU economic operator has the following tasks:

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

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

3.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. 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.

 360Compliance provides Testing & Certification for type approval services and global market access in 195 countries. With proven expertise in worldwide regulations, 360Compliance can help your company shorten time to any market, minimize risks and manage the regulatory process from A-Z.

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