European Authorized Representative (EC REP / EAR) Services
For medical device and IVD manufacturers located outside the EU/EEA, appointing a legally designated European Authorized Representative (EC REP) is a mandatory prerequisite to place products on the Union market.
Core EAR Responsibilities & Capabilities
Device Registration with EU Competent Authorities
As your appointed European Authorized Representative (EAR), NKB Regovanta fulfills all MDR/IVDR local representation mandates for non-EU manufacturers, facilitating direct device registration and maintaining mandatory regulatory records.
Documentation & Technical Conformity Assurance
Our regulatory compliance experts conduct rigorous verifications of your Declaration of Conformity (DoC), CE Certificates, and Annex II/III Technical Files to ensure continuous audit readiness.
Direct Competent Authority & Notified Body Liaison
NKB Regovanta manages all formal communications, safety inquiries, and clarification requests from EU Competent Authorities and Notified Bodies on your behalf.
Vigilance & Incident Communication
We serve as the primary conduit for safety notifications, coordinating Field Safety Corrective Actions (FSCA), Field Safety Notices (FSN), and serious incident reporting.
Inspection & Audit Representation
We maintain all statutorily required files, official correspondence, and post-market records immediately accessible for authority inspections and audits.
Active Regulatory Guardianship Across 27 Member States
We do not act as passive mailbox representatives. We actively safeguard your commercial access, scrutinize labeling and PRRC qualifications, verify technical documentation completeness, and interface with European authorities.
EC REP Mandate Requirements
- • Written mandate contract per Article 11
- • Verified PRRC availability at EC REP
- • Technical file access & 10/15-year archiving
- • EUDAMED Actor Registration & SRN linkage
Appoint Your EAR
Establish legally compliant representation in the European Union.
Request EC REP AgreementSecure Legally Mandated Representation Across the European Union
Partner with NKB Regovanta as your European Authorized Representative (EC REP).