EU Authorised Representative
Looking to gain access to the medical device market in the EU? Trinzo can make that possible.
The European Union requires foreign manufacturers who intend to sell their devices in any of the Member States to designate an authorised representative with a physical address within one of the Member States.
At Trinzo, our experienced team can offer a EU Authorised Representative Service from our registered offices in Ireland.
What's included in the service?
Regulatory pre-compliance check for the EU against the requirements of the EU MDR
Advice and assistance for device registrations, as required
Use of name and registered address on your product labelling throughout Europe
A detailed review of your EU declaration of conformity, technical documentation and QMS
Updates regarding regulatory changes which might impact compliance
Informing the manufacturer of any complaints and vigilance reports received in the EU
Retention of a European Authorised Representative and a Person Responsible for Regulatory Compliance to act on behalf of your company in the EU
How much will it cost?
The cost for our EU Authorised Representative Service is dependant on your product type and risk class. Book in your free, no obligation consultation with a member of our team today.
Ready to appoint us as your EU Authorised Representative?
Contact our team today for a formal quotation.