EU Authorised Representative for Non Medical Products
Appointing an Economic Operator
For Manufacturers with no legal presence in the EU, the simplest way to meet the requirement to have an Economic Operator is to appoint an Authorised Representative. Doing so allows them to identify the same Economic Operator for every product they place on the market in the EU, irrespective of where its sold or via which channel. It also avoids the need to complicate other commercial relationships by imposing long-term responsibilities on Importers or Fulfilment Services Providers.
Why do I need an Economic Operator?
Since July 2021, under the EU Market Surveillance Regulation 2019/1020, many products made available for purchase in the European Single Market must have an identified ‘Economic Operator’ established in the European Union. Failure to identify an Economic Operator can result in goods being denied entry into the Single Market, potentially resulting in delays to deliveries or cancellations of orders.
Why use Eurolink as your EU Authorised Representative?
As an EU Authorised Representative, in addition to allowing Manufacturers to identify an Economic Operator for their products, we can and do provide clients with a variety of additional specialist services such as:
- Allowing registration of products on the EPREL database, and the generation of Energy Labels, in accordance with EcoDesign Regulations
- Registering both Manufacturers and Products on the EU NOISE Portal in accordance with the Outdoor Noise Directive 2000/14/EC
- Acting as the ‘Responsible Person’ in accordance with Regulation (EC) No 1223/2009 on Cosmetic Products and notifying products on behalf of Manufacturers in the Cosmetic Products Notification Portal (CPNP)
Clients who don’t require such specialist support still benefit from a wide range of services when working with Eurolink Europe, including:
- Checking of Technical Documentation to ensure the requirements of applicable EU Directives and Regulations have been met and when necessary, supporting the creation of additional documentation.
- Use of Eurolink Europe company details on product labels and documentation, including Declarations of Conformity
- Issuing of Declarations of Conformity when requested.
- Retention of Technical Documentation within the EU to ensure that it is at the disposal of the Competent Authorities if requested.
- Cooperation with the Competent Authorities if required
- Liaison, when required, with other Actors within Device supply chains, including Importers and Distributors
- Delivery of updates on regulatory changes impacting Manufacturers’ devices
- Provision of general Advisory Services when requested, to support ongoing compliance efforts.
• Over 30 years experience.
• Single service provider for both the EU and UK markets.
• Extensive portfolio of customers across multiple industries and sectors.
• Thousand of products represented.
• Expert knowledge on the regulatory compliance industry.
• Competitive fees and customer focused service.
• Flexible and highly responsive.
• We will always find time to understand and guide you through any challenges you may have.
• We are able to provide advice and guidance or interact directly with Regulatory Authorities on your behalf.
