EU Authorized Representative for Medical Devices

Accessing the European Union Market

Non-EU manufacturers intending to market their medical devices or in vitro diagnostic devices in the European Union are legally required to appoint a European Authorized Representative (EU-REP) under Regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR).

The EU-REP acts as the official legal interface between the non-EU manufacturer and EU Competent Authorities, Notified Bodies, and EUDAMED.

ALTRION serves as your trusted representative in Europe, ensuring full regulatory compliance, traceability, and efficient communication with authorities throughout the entire product lifecycle.

Our Services

EU-REP Appointment & EUDAMED Registration

• Formal appointment as EU-REP
• Actor registration in EUDAMED and issuance of SRN (Single Registration Number)

Documentation Oversight

• Verification and continuous monitoring of the Declaration of Conformity (DoC)
• Review of Technical Documentation in line with Annex II & III of MDR/IVDR

Regulatory Communication

• Direct communication with Competent Authorities and Notified Bodies
• Representation on behalf of the manufacturer

Post-Market Activities

• Support for vigilance reporting
• Coordination of Field Safety Corrective Actions (FSCA)
• Post-Market Surveillance (PMS) support

Documentation Management

• Archiving of regulatory documentation
• Management of risk management files, clinical evaluation, labeling, and IFUs

Change Management

• Support for updates to products or documentation
• Ensuring continuous compliance throughout lifecycle changes

Audits & Inspections

• Representation during audits and inspections by Authorities or Notified Bodies

Regulatory Intelligence (Optional)

• Monitoring of MDR/IVDR updates and EU regulatory publications

Italian Market Registration

As part of its EU-REP services, ALTRION ensures the registration of medical devices in the Italian Ministry of Health database, in compliance with Article 29 of Regulation (EU) 2017/745 and the Italian Decree of 21 December 2009 (and subsequent updates).

This registration is mandatory for all devices marketed in Italy and ensures full traceability within the national medical device database.

Registration Services Include

• Verification of documentation consistency prior to submission
• Preparation and upload of product data into the Ministry of Health portal (Banca Dati dei Dispositivi Medici)
• Management of UDI and Basic UDI-DI mapping according to MDR requirements
• Communication of registration confirmation and assigned codes to the manufacturer

Our Approach

By managing EU-REP responsibilities and national registrations directly, ALTRION ensures that all devices are fully compliant, traceable, and ready for placement on the European market without delays.