Why You Need an EU Authorised Representative
If you supply products, including CE marked products such as machinery, into the EU, compliance with Regulation 2019/1020 on market surveillance and compliance of products is mandatory. This regulation, effective since July 16, 2021, strengthens market surveillance requirements for member states and has significant implications for manufacturers and suppliers. Regulation 2019/1020 mandates that certain goods cannot be placed on the EU market unless an "economic operator" is established within the EU. For many manufacturers outside the EU, this means appointing an EU Authorised Representative. This EU Authorised Representative acts as your point of contact for market surveillance authorities and ensures compliance with EU regulations.
For businesses outside the EU, including those in the UK, understanding the role of an economic operator is crucial for compliance with EU regulations. The economic operator is responsible for maintaining conformity documentation, cooperating with market surveillance authorities, and notifying authorities of any product risk. While several entities can act as the economic operator—including the manufacturer, importer, or fulfilment service provider—many businesses choose to appoint an EU Authorised Representative.
The Regulation defines the economic operator as one of the following:
- The manufacturer (any person who manufactures a product or has it designed/manufactured and markets it under their name/trademark).
- The importer (any EU-established person who places a product from a third country on the EU market).
- The EU Authorised Representative (any EU-established person with a written mandate from the manufacturer to act on their behalf regarding specified tasks related to EU harmonisation legislation).
- The fulfilment service provider (any person offering at least two of the following services: warehousing, packaging, addressing, and dispatching, without owning the products, excluding specific postal and freight services).
Appointing an EU Authorised Representative offers a practical solution for non-EU manufacturers, ensuring compliance with EU regulations without necessarily establishing a physical presence within the Union. This representative acts as a point of contact for market surveillance authorities and ensures all necessary documentation is readily available.
Note: An importer may work for several manufacturers, meaning it may not be necessary for the manufacturer to share intellectual property in the technical file with an importer.
Navigating EU product compliance can be complex, especially for businesses based outside the EU, like those in the UK. A key role in this process is the EU Authorised Representative. Economic operators, responsible for ensuring product conformity, cooperating with market surveillance authorities, and informing authorities of potential product risks, are crucial. For manufacturers outside the EU, this responsibility often falls to their EU Authorised Representative.
The Regulation defines several economic operators: the manufacturer, the importer, the EU Authorised Representative, or a fulfilment service provider. An EU Authorised Representative is a natural or legal person established within the EU, mandated by a manufacturer to act on their behalf regarding specific tasks related to EU harmonisation legislation. This includes cooperating with authorities.
Originally, non-EU machinery manufacturers needed someone to compile the Technical File identified on the Declaration of Conformity. Their responsibility was limited to providing this file upon request. However, Regulation 2019/1020, effective from July 16, 2021, mandated an EU Authorised Representative with a mandate to cooperate with authorities if no other economic operator existed. This EU Authorised Representative could also compile the Technical File. This particular provision concerning the EU Authorised Representative and the Technical File will be removed on January 20, 2027, when the EU 2023/1230 Machinery Regulation replaces the 2006/42/EC Machinery Directive.
These requirements apply to products under Annex I of Regulation 2019/1020, including those covered by directives like the Machinery Directive (2006/42/EC), EMC Directive (2014/30/EU), Low Voltage Directive (2014/35/EU), and Pressure Equipment Directive (2014/68/EU).
The establishment of the Union Product Compliance Network in January 2021 further emphasises the importance of complying with the economic operator and EU Authorised Representative requirements. This network facilitates coordination between member state enforcement authorities and the Commission, enhancing market surveillance effectiveness. Therefore, having a designated and compliant EU Authorised Representative is more critical than ever for non-EU manufacturers seeking to access the EU market.
Hold Tech Files Ltd can act as the Authorised Representative for any of the Directives or Regulations listed in Annex I of Regulation 2019/1020.
Hold Tech Files can act as EU AR for manufacturers of products not subject to CE marking but that comes under the General Product Safety Regulations (EU) 2023/988.
For more information, email derek@holdtechfiles.eu.
+44 7827 908940
UK Health and Safety Executive have advice on Authorised Representative requirements.
The Europa website has information about Market Surveillance.