The EU Medical Device Regulation (EU-MDR, 2017/745) raised the bar for how medical devices are designed, documented and monitored across the European Union. For clinicians it means stronger safety and traceability; for distributors it means clearer, more complete technical documentation.

How we support you

  • Devices manufactured under an ISO 13485 quality system.
  • EU-MDR-aligned technical documentation and declarations of conformity.
  • CE marking and FDA registration where applicable.

For approved partners, we provide the documentation packs needed to register and place AUG Medical devices on your market. Visit our Quality & Certifications page or request access through the resource centre.