EU authorised representative in Spain.
For manufacturers established outside the EU: a direct route to discuss MDR/IVDR authorised representation, with clearly scoped responsibilities and controlled regulatory evidence.
Registered actor identity
Authorised Representative: Ali Iskandar (Spain)
EUDAMED Actor ID / SRN: ES-AR-000060462
Service brand: ClinicOps
EUDAMED actor registration identifies the economic operator. It does not appoint an authorised representative for any particular manufacturer or device. Each engagement requires an accepted written mandate.
How representation is scoped
- Identify the manufacturer, applicable MDR/IVDR role and device families.
- Review manufacturer documentation, responsibilities, proposed scope and practical access arrangements.
- Agree a written mandate and appropriate compliance and contractual arrangements before acceptance.
- Establish communication, controlled records, manufacturer change notification, vigilance escalation and EUDAMED mandate processes.
- Route open evidence questions to named, qualified human decision-makers.
Regulatory integrity alongside representation
Separate from the AR mandate, ClinicOps offers evidence-based reconciliation of approved device information against Basic UDI-DI / UDI-DI records, certificates, declarations, IFUs, labels, SS(C)P and controlled documents. The output is a reviewer-ready exception queue, not an automatic compliance verdict.
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Initial conversation
Share your manufacturer jurisdiction, device types, applicable regulatory framework and the question you need resolved. Please do not email patient-identifiable information, proprietary technical files or personal documents before secure handling is arranged.