Medical Device Authorized Representative - EU Authorized Representative (EUAR) and UK Responsible Person (UKRP)

Non-European Union (EU) and non-UK medical device manufacturers must designate an authorized representative to act on their behalf to ensure compliance with EU and UK medical device regulations. In the EU, this role is referred to as the European Authorized Representative (EUAR), while in the UK, it is known as the UK Responsible Person (UKRP). Although the terminology differs, both roles share similar responsibilities, and for internal purposes, we may collectively refer to them as the EU/UK Medical Device Authorized Representative.

Role and Responsibilities

Your EU/UK Medical Device Authorized Representative serves as the primary point of contact between your organization (as a non-European manufacturer), the national EU/UK Competent Authorities (e.g., Ministries of Health), and Notified Bodies. Their key responsibilities include:

• Ensuring compliance with relevant EU Medical Device Regulations (MDR) and UK Medical Device Regulations.
• Managing and maintaining technical documentation.
• Facilitating communication with regulatory authorities and Notified Bodies.
• Handling incident and vigilance reporting.
• Ensuring product labeling and instructions meet regulatory requirements.

Why Designate an EU/UK Authorized Representative?

Designating an EU/UK Medical Device Authorized Representative is not just a regulatory requirement but also a strategic move to streamline market access and regulatory compliance. The representative ensures that your medical devices meet the stringent safety and performance requirements laid out in EU and UK medical device regulations.

By partnering with a reliable EU/UK Medical Device Authorized Representative, manufacturers can confidently navigate the complex regulatory landscapes of both regions, ensuring seamless market entry and ongoing compliance.