Compliance for Medical Devices in the European Union
Our Authorized Representative and Responsible Person services provide expert guidance for swift and safe market entry, tailored to meet the diverse needs of businesses. We span regulations in the EU, UK, US and beyond to support your compliance needs effectively.
FAQs
What is a European Authorized Representative?
A European Authorized Representative is an EU-based entity appointed by a non-EU manufacturer to handle regulatory responsibilities.
Is an EU AR mandatory?
Yes, it is mandatory for non-EU manufacturers placing medical devices on the EU market.
What does an EU AR do?
An EU AR ensures compliance, maintains documentation, and communicates with authorities.
Can I sell in the EU without an EU AR?
No, non-EU manufacturers must appoint a European Authorized Representative.
Does the EU AR hold responsibility?
Yes, the EU AR shares certain regulatory responsibilities under MDR and IVDR.