Your Official EU Legal Representative. Based in Germany.

Manufacturers outside the EU are required to appoint an Authorized Representative (AR) within the European Union, for medical devices it is clearly regulated under MDR Art. 11 and IVDR Art. 11.
We offer a full mandate as your EU Authorized Representative: ● one point of contact● one contract● full regulatory responsibility.
We are your official address in the EU. We communicate with authorities and Notified Bodies, manage your documentation, and secure your market access – so you can focus on your product and your business.

Our Solution

We are your official address in the EU. We communicate with authorities and Notified Bodies, manage your documentation, and secure your market access – so you can focus on your product and your business.

Scope of Services

Registration & Setup EUDAMED/ company/ product registration, national authorities, review of technical documentation for EU conformity.
Ongoing Compliance Authority communication, document management, regulatory updates, and risk management.
Post-Market Surveillance Vigilance, adverse event reporting, recalls, and market surveillance under MDR/IVDR.
Multilingual Support English, German, and additional languages – direct communication without translation loss.

Pricing Model

Transparent and predictable.
• One-time registration fee
• Annual service fee
• Tiered by risk class and product complexity