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European Union Launches New Regulation on Market Surveillance and Compliance of Products
  >  
European Union Launches New Regulation on Market Surveillance and Compliance of Products

European Union Launches New Regulation on Market Surveillance and Compliance of Products

The GMA Consult Group reminds our subscribers about 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. The document became effective from July 16, 2021

The Regulation was developed as a control instrument for products on the EU market for reasons of consumers’ safety. Thus, the supplied device must meet the requirements of the EU harmonized legislation to show its reliability and safety.

Due to the fact that e-trading has become very popular nowadays, the new Regulation (EU) 2019/1020 set requirements not only to the physical EU market but to e-commerce as well. Thus, consumers buying through an online platform in the EU may be protected against getting low-quality items.

The Regulation establishes terms for businesses outside the EU. According to these terms, the manufacturer that is located outside the EU must have an EU authorized representative. Otherwise, functions of the manufacturer will be laid upon a fulfillment service provider established in the EU for products handled by it.

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

  • keep technical file on the product and EU declaration (if any)
  • provide this file upon request when showing the compliance of the product to the EU legislation. Additionally, the technical file must be in the national language of that member-state where the product is going to be sold
  • If it is stated that the product poses risk to the consumer, the economic operator must notify the market surveillance authorities thereof

This Regulation applies to non-food products but to 70 Regulations and Directives referring to different types of product, among which are: 

  • Medical devices
  • Toys
  • Radio equipment
  • Motor vehicles 
  • Household appliances
  • Pressure equipment
  • Electrical and electronic equipment

 

The new Regulation also allows speeding up the market surveillance procedure within the EU via the Union Product Compliance Network - a platform for cooperation and collaboration between authorities of the Member States and the European Commission.

Please, take into consideration that the UK is not an EU member from 2021 and for the manufacturers from the UK it is necessary to have an EU economic operator to sell production both in the EU market directly or through the online platform. 

 

The text of the Regulation itself you can find here.


The information has been prepared by the GMA Consult Group team.

GMA Consult Group provides a full cycle of international type approval and global market access services for IT, Telecom, and industrial electrical products in all countries throughout the world. With proven expertise in worldwide regulations, compliance, certification, and conformity assessment, GMA Consult Group can help your company speed up the access to any market with almost zero efforts from your side.

Need your own guide to the world of certification and approvals? Don't hesitate to contact us via info@gma.trade.

August 2, 2021

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