If you export to the European Union, you may need to appoint an authorised representative (AR) to comply with a new Regulation that comes into force on 16 July.
European Union (EU) Regulation 2019/1020 on market surveillance and compliance aims to improve the ‘policing’ of markets to ensure products comply with Regulations and Directives. 70 product Directives are covered, including:
- 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)
- 94/9/EC ATEX Equipment
Other product Directives are as diverse as personal protective equipment (PPE), toys and recreational craft.
Regulation 2019/1020 places new obligations on Member States and market authorities, and also has important implications for manufacturers exporting to the EU, which includes those in the UK. Specifically, Regulation 2019/1020 prohibits goods from being placed on the market unless there is an ‘economic operator’ established in the EU. Economic operators are responsible for ensuring conformity documentation is available, co-operating with market surveillance authorities and informing authorities if a product presents a risk.
Without an economic operator, goods being exported to the EU could be held at customs. Resolving this would be costly and time-consuming.
Non-EU manufacturers are restricted to using an importer, AR or fulfilment service provider as the economic operator. For engineering products or those with complex compliance requirements, it is unlikely that many importers or fulfilment service providers would be competent or willing to take on the responsibilities. Furthermore, appointing an importer could entail sharing commercially sensitive intellectual property contained in technical files. Consequently, an AR is often the only viable option.
An AR is a natural or legal person established within the EU who has a written mandate from a manufacturer to act on its behalf under the terms of Regulation 2019/1020. However, the AR needs to be competent to understand the conformity documentation and ensure it is suitable for purpose. The AR must also be ready to respond to enquiries from market surveillance authorities.
Hold Tech Files Ltd is based in the Republic of Ireland and is therefore established in the EU as required by Regulation 2019/1020. The company’s specialists are familiar with regulatory compliance, enabling it to offer a cost-effective service whereby it acts as an AR for any applicable products.
To find out more about appointing an authorised representative or to download a white paper about Regulation 2019/1020, visit www.holdtechfiles.eu or email [email protected]
