EU Authorised Representative for Medical Devices (MDR)
We act as your EU Authorised Representative and help you set up a workable compliance process for placing medical devices on the EU market.
For whom
- Manufacturers established outside the EU placing medical devices on the EU market
- Companies transitioning from MDD to MDR
- Manufacturers needing EU representation + PRRC and registration support
Our onboarding approach
- Scope confirmation: device type, class, intended purpose, market model (importer/distributor)
- Document readiness: basic review of the technical documentation structure and key declarations
- Mandate setup: clear written mandate and working communication channels
- Operational setup: how requests, vigilance signals, and updates will be handled
Typical deliverables
- EU AR mandate wording (aligned with your business model)
- Onboarding checklist and document list
- Regulatory communication workflow (who answers what, and within which time)
- Registration support plan (e.g., EUDAMED steps, where applicable)
EUDAMED: We are registered in EUDAMED as an Economic Operator (EO) — European Authorised Representative (EAR). View our EUDAMED entry.
Note: Requirements depend on your device, classification, and market model. We start with a short scoping call and a document list.
