Authorised Representative (EU)
What is Authorised Representative?
An Authorised Representative (EU) is a natural or legal person established within the European Union who is formally appointed by a non-EU manufacturer to act on their behalf for specific regulatory compliance obligations. Under various EU regulations, certain products cannot be placed on the EU market unless an EU-based representative has been designated.
Why It Matters
If your company is located outside the EU but sells products to customers within the European Union, you may legally need an EU Authorised Representative.
This role ensures there is a responsible entity established within the EU who can communicate directly with market surveillance authorities, provide technical documentation, and assist with enforcement inquiries or corrective actions. Without a required Authorised Representative, products may be stopped at customs, removed from online marketplaces, or subject to fines and recalls.
For ecommerce sellers, manufacturers, and brand owners, appointing an Authorised Representative is often essential for lawful market access.
Key Requirements
Who Needs an Authorised Representative?
An EU Authorised Representative is generally required when:
- The manufacturer is established outside the EU,
- The applicable EU regulation mandates EU-based representation.
This requirement applies under several regulatory frameworks, including:
- Regulation (EU) 2023/988 – General Product Safety Regulation (GPSR)
- Regulation (EU) 2017/745 – EU Medical Device Regulation (MDR)
- Regulation (EU) 2017/746 – In Vitro Diagnostic Regulation (IVDR)
- Certain CE marking directives and regulations requiring an EU economic operator
Not all product categories require an Authorised Representative, but many regulated products do.
While obligations vary depending on the regulation, responsibilities commonly include:
- Holding or verifying the manufacturer’s technical documentation
- Providing documentation to competent authorities upon request
- Cooperating with market surveillance authorities
- Assisting with corrective actions, product recalls, or safety investigations
- Ensuring required identification details appear correctly on product labelling
- Acting as a contact point for regulatory communication
EU vs UK Requirements
Following Brexit, the EU and UK operate separate regulatory systems.
- For products sold in the European Union, an EU Authorised Representative may be required.
- For products placed on the market in Great Britain, a UK Responsible Person (UKRP) may be required instead.
These roles are not interchangeable. Businesses selling in both regions often need both an EU Authorised Representative and a UK Responsible Person to ensure compliance across markets.
Is an Authorised Representative the
Same as an Importer?
No. An Importer is the entity that places a product from a third country onto the EU
market. An Authorised Representative acts on behalf of the manufacturer for specific regulatory obligations. In some cases, the same entity may perform both roles, but
their legal responsibilities differ.
Need GPSR compliance support?
Euverify provides EU Authorised Representative services for manufacturers and ecommerce sellers placing products on the EU market. Our team supports documentation review, regulatory communication, and ongoing compliance management.
Further Reading
