EU Authorized Representative
for medical devices
Certification for placing on the market
of medical devices and IVDs in the European Union
EU Authorized Representative
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 the 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 product lifecycle.
Our Services
- Formal appointment as EU-REP and Actor registration in EUDAMED (obtaining SRN – Single Registration Number)
- Verification and continuous monitoring of the manufacturer’s Declaration of Conformity (DoC) and Technical Documentation as per Annexes II and III of MDR/IVDR
- Support for vigilance, Field Safety Corrective Actions (FSCA), and Post-Market Surveillance (PMS) coordination
- Direct communication with Competent Authorities and Notified Bodies on behalf of the manufacturer
- Archiving of regulatory documentation, including risk management, clinical evaluation, labeling, and IFUs
- Change management to ensure compliant handling of product or documentation updates
- Representation during audits and inspections carried out by Authorities or Notified Bodies
- Optional Regulatory Intelligence service to monitor and report new MDR/IVDR guidance and EU publications
Registration with the Italian Ministry of Health
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 serves to guarantee full traceability within the national medical device database.
ALTRION manages the entire process, including:
- Verification of documentation consistency before submission
- Preparation and upload of product data into the Ministero della Salute portal (Banca Dati dei Dispositivi Medici)
- Management of the UDI and Basic UDI-DI mapping according to MDR requirements
- Communication of registration confirmation and assigned codes to the manufacturer
By handling this activity directly, ALTRION ensures that all devices are duly registered and compliant before being placed on the Italian market.
Why Choose ALTRION
- EU-based, multilingual regulatory team experienced in MDR/IVDR compliance
- Proven experience managing legacy and transition devices from MDD/IVDD to MDR/IVDR
- Centralized regulatory document control and secure vigilance tracking
- Transparent contracts, renewable annually, with no hidden costs
- Part of a global compliance network offering CH-REP (Switzerland), UKRP (United Kingdom), and US FDA Agent services for worldwide market access
Deliverables
- EU-REP Designation Letter and Service Agreement compliant with MDR/IVDR Article 11
- EUDAMED registration confirmation and issuance of Actor ID (SRN)
- Confirmation of Italian Ministry of Health registration (if applicable)
- Contact information for labeling and technical documentation
- Annual PMS and vigilance summary, with full communication log
- Support in regulatory responses and CAPA documentation when required
Are you looking for an EU Authorized Representative
for medical devices?
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