(EU) 2019/1020 Market surveillance regulation and compliance of products

Market surveillance regulation and compliance of products

In addition to specific product-related directives and regulations - such as the Machinery Directive, EMC Directive and Low Voltage Directive for example - generic product regulations must also be considered when placing products on the European market.

One of these is the regulation - (EU) 2019/1020 on market surveillance and compliance of products, which came into force in July 2021.

Regulations are effective immediately as, unlike directives, they do not need to be converted into domestic law first.

Role of economic operators

Role of economic operators

The regulation on market surveillance governs the role of the various economic operators: manufacturers, authorised representatives, importers. It defines and standardises their tasks with regard to the placing of products on the market.

The aim of the market surveillance regulation is to boost consumer confidence in CE-marked products and protect consumers from unsafe products. This aim is to be achieved by increasing market surveillance. A further aim is to ensure that only compliant products that meet the European Union's requirements for a high level of protection are made available on the European single market. Also, a level playing field is to be created for all economic operators, in terms of competition.

The regulation will also provide better tools for market surveillance. Greater attention will be paid to e-commerce and online trade.

Main provisions of (EU) 2019/1020

Article four contains the most important, direct new features for manufacturers or importers. The regulation (EU) 2019/1020 states that products may only be placed on the market if there is an economic operator established in the Union, who must be one of the following operators:

  • A manufacturer established in the Union
  • An importer (by definition established in the Union), where the manufacturer is not established in the Union
  • An authorised representative established in the Union, who has a written mandate from the manufacturer
  • A fulfilment service provider (primarily online sales) established in the Union, where there is no manufacturer, importer or authorised representative established in the Union

There is new obligation to name a "representative" established in the European Union, if the manufacturer himself is not established in the European Union.

As a result, in future, economic operators will include not only manufacturers, importers and authorised representatives but also "fulfilment service providers". These are any natural or legal persons offering, in the course of commercial activity, at least two of the following services: warehousing, packaging, addressing and dispatching of products, without having ownership of the products involved. The intention in including fulfilment service providers is to ensure that there is always an economic operator established in the EU, who is responsible for fulfilling the obligations.

The obligations of the economic operators include, in particular:

  • Verification that an EU declaration of conformity and the stipulated technical documentation for the respective product have been drawn up and archived
  • A copy of the declaration of conformity should be retained in case it should be requested by the market surveillance authorities. It is necessary to ensure that the technical documentation can be made available to the market surveillance authorities upon request. Technical documentation must be drawn up in a language that can be easily understood by the authority
  • Cooperation with the market surveillance authorities, making sure that the immediate, necessary, corrective action is taken to remedy any case of non-compliance or, if that is not possible, to mitigate the risks presented by that product
  • The name and address of the responsible economic operator shall be indicated on the product, the packaging, the parcel or accompanying documents
  • If there are any indications that products are hazardous, inform the market surveillance authorities and, if appropriate, initiate corrective actions

What's new?

What's new here is that the whole range of obligations now apply equally to all economic operators. The obligations described refer to products that fall under the scope of one of more of the following directives or regulations, for example:

  • 2006/42/EC Machinery Directive
  • 2014/30/EU EMC Directive
  • 2014/35/EU Low Voltage Directive
  • 2014/68/EU Pressure Equipment Directive

Impact on operators

Impact on operators

As the operating company you should make absolutely sure that only machinery with a clearly named economic operator enters the EU. Should that not be case, as the operating company you will act as the importer and must fulfil all the obligations stated above.

How can we provide support?

Thanks to our many years of experience and extensive expertise, Pilz can support you in all phases of the plant and machine lifecycle. We can guarantee compliance with regulatory requirements, such as CE marking in Europe, for example . We act as the authorised representative for many companies worldwide - contact us and let us advise you without obligation!

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Further information:

Our services:

Overview of all generic product regulations

Contact

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Pune - 411037
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Telephone: +91 20 49221100/101/102
E-Mail: info@pilz.in

Technical Support

Telephone: +91 20 49221100/101/102
E-Mail: info@pilz.in

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