Machine manufacturers and the need for EU Authorised Representatives
STORAGE , HANDLING & DISTRIBUTION
SECURE STORAGE
HOLD TECH FILES LTD
Machine manufacturers and the need for EU Authorised Representatives
If you export to the European Union , you may have heard about EU Authorised Representatives and be wondering what they are . How do they differ from distributors or importers ? What do they have to do ? Who should have one and how are they appointed ? In this article we will explain the regulatory requirements and what you need to know about Authorised Representatives .
All the talk about Authorised Representatives ( ARs ) stems from the European Union ( EU ) Regulation 2019 / 1020 on market surveillance and compliance of products . This came into force on 16 July 2021 with the aim of improving the ‘ policing ’ of markets in the EU to ensure products comply with applicable regulations and directives . Although Regulation 2019 / 1020 has been in force for over two years , there is still a widespread lack of awareness among UK businesses exporting to the EU .
Annex I of Regulation 2019 / 1020 lists approximately 70 product directives that are affected . Examples from the industrial sector include :
• 2006 / 42 / EC Machinery Directive
• 2014 / 30 / EU Electromagnetic Compatibility ( EMC ) Directive
• 2014 / 35 / EU Low Voltage Directive ( LVD )
• 2014 / 29 / EU Simple Pressure Vessels Directive ( SPVD )
• 2014 / 68 / EU Pressure Equipment Directive ( PED )
• 2014 / 34 / EU ATEX Equipment
Other directives listed in Annex I cover products as diverse as
As well as being appointed as an AR , Hold Tech Files can also be named on the DoC or DoI as the person authorised to compile the technical file .
personal protective equipment ( PPE ), toys and recreational craft .
While Regulation 2019 / 1020 places obligations on Member States and their market authorities , it also has important implications for manufacturers that export to the EU – and this includes the UK now it is no longer a member of the EU . Specifically , Regulation 2019 / 1020 contains requirements relating to an ‘ economic operator ’. Without an economic operator established in the EU , you are prohibited from placing goods on the market .
The economic operator is responsible for ensuring the conformity documentation is available , co-operating with market surveillance authorities and informing authorities if there are reasons to believe a product presents a risk .
According to Regulation 2019 / 1020 , an economic operator can be any of the following : the manufacturer ; the importer ; an authorised representative ; or a fulfilment service provider when none of the foregoing are established in the EU . Article 3 of the Regulation provides definitions for these four terms .
If a manufacturer is based outside the EU , the options for an economic operator are restricted to an importer , AR or fulfilment service provider . For industrial products or those where regulatory compliance is complex , it is unlikely that an importer or fulfilment service provider will be competent or willing to take on the responsibilities of being the economic operator .
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