EU Authorised Representative
If you are a medical device manufacturer looking to gain access to the medical device market in EU, our team 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 Meddev Solutions, our experienced, award winning team can offer a EU Authorised Representative Service from our registered offices in Northern Ireland under the Protocol agreed between the UK and Europe (Northern Ireland Protocol).
If you also require access to the UK market, our unique position allows us to act as your UK Responsible Person. For more information on our UK Responsible services, please contact us.
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.