Representing non-EU based manufacturers in a successful EU Market entry and safeguarding their future across the European community.
Any non-EU based manufacturer which wishes to make their goods available within the EU market requires an EU based entity which meets the requirements as laid out in the applicable legislation(s) in addition to representing them before the Competent Authorities. Depending on the legislation, this may be referred to as European Authorized Representative (EC REP) or EU Responsible Person (EU RP).
While the EU is an economic and political union, it is still not one single country. It requires a professional representative to support you in navigating the complexities of changing legislation along with economic and political upheavals across any and all of the 27 EU Member States, 4 EFTA countries and the UK.
Authorized Representative (EC REP)
- Provide a registered address in the European Union
- Keep available the Technical Documentation for inspection by the European Authorities.
- Complete Notification to the European Authorities
- Complete (any) registration to National Databases
- Take care of (any) incident reporting
- Represent the manufacturer towards the Commission, Authorities and Notified Bodies.
- Safeguard compliance with constant regulatory updates.
- Consult on European Regulations.
EU Responsible Person
A professional EU Representative should be able to support you by:
- Guiding your through the appropriate compliance pathway(s)
- Trade Mark submission
- Documentation Review, Keeping & Updating
- EU Label & Claims Review
- Translations and Language Requirements
- Pre-market Notifications (Product Registration)
- Serving as your EU Address and Vigilance Contact Point
- Country specific requirements / Registrations
- Incident Reporting & Compliant Handling
- Product Recalls
- EU Competent Authority correspondence
- Post-Market Surveillance
- Remaining Compliance as the Laws Evolve...
... thus ensuring a smooth EU Market penetration while also safeguarding continued success in an ever-changing marketplace.
Interested in other global markets? Learn more about how Obelis clients in the EU Market gain access to the Obelis global partners (OIO network) for further global solutions and support.Get in touch