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, also known as 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. This role is essential for ensuring regulatory compliance, traceability and efficient communication throughout the product life cycle.
ALTRION serves as your trusted representative in Europe, supporting medical device and IVD manufacturers with EU-REP appointment, EUDAMED registration, documentation review, vigilance coordination, regulatory communication and ongoing compliance management.
EUDAMED Registration and EU Authorised Representative (EU-REP)
ALTRION supports the formal appointment as EU Authorised Representative (EU-REP) and manages the EUDAMED registration activities required under Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR).
Our services include the registration of economic operators (Actor Registration) and the acquisition of the SRN (Single Registration Number), allowing non-EU manufacturers to establish the regulatory presence required to access the European market and ensuring that all relevant actor information is correctly registered and available to Competent Authorities.
Since 28 May 2026, the EUDAMED Actor Registration and UDI/Device Registration modules have become mandatory. New MDR and IVDR devices must be registered in EUDAMED before being placed on the European market, while transitional provisions apply to certain devices already placed on the market before the mandatory use date.
ALTRION assists manufacturers throughout the entire EUDAMED registration process, including:
- EU-REP appointment and mandate management;
- EUDAMED Actor Registration and SRN acquisition;
- Verification of consistency between EUDAMED data, technical documentation, certificates and Declarations of Conformity;
- Registration of Basic UDI-DI and UDI-DI information;
- Device Registration within EUDAMED in accordance with MDR and IVDR requirements;
- Management of updates, changes and maintenance of EUDAMED records throughout the device lifecycle;
- Support during interactions with Competent Authorities and Notified Bodies regarding EUDAMED registrations.
A properly managed EU-REP appointment and EUDAMED registration strategy form the foundation for compliant access to the European market. ALTRION helps manufacturers establish a clear regulatory framework, ensuring effective communication between the non-EU manufacturer, European authorities and the European regulatory system while maintaining ongoing compliance with MDR and IVDR requirements.
Declaration of Conformity and Technical Documentation review
As part of its EU-REP services, ALTRION verifies and continuously monitors the manufacturer’s Declaration of Conformity and Technical Documentation according to Annexes II and III of MDR and IVDR.
This review helps ensure that the documentation supporting the device is consistent, complete and aligned with the applicable regulatory framework. ALTRION also supports the archiving of regulatory documentation, including risk management, clinical evaluation, labeling and Instructions for Use, so that the required information remains organized and available when needed.
Vigilance, FSCA and PMS coordination
EU-REP responsibilities continue after the device has been placed on the market. ALTRION supports vigilance activities, Field Safety Corrective Actions (FSCA) and Post-Market Surveillance (PMS) coordination, helping manufacturers manage safety-related information and post-market obligations in the European Union.
This support is important for maintaining compliance throughout the device life cycle. ALTRION helps ensure that vigilance data, PMS information and corrective actions are handled in a structured way and communicated properly when required.
Communication with Competent Authorities and Notified Bodies
ALTRION provides direct communication with Competent Authorities and Notified Bodies on behalf of the manufacturer. This service helps non-EU manufacturers manage official requests, regulatory follow-up, audits, inspections and authority communications through an EU-based representative.
Efficient communication is especially important when documentation, safety information or product updates need to be clarified. ALTRION acts as a reliable regulatory contact point, helping manufacturers maintain continuity and responsiveness.
Change management and regulatory intelligence
Product or documentation updates must be managed carefully to remain compliant with MDR and IVDR requirements. ALTRION supports change management to ensure that updates are handled in a controlled and compliant manner.
An optional Regulatory Intelligence service is also available to monitor and report new MDR/IVDR guidance and EU publications. This helps manufacturers stay informed about regulatory developments that may affect documentation, post-market activities or market access obligations.
Representation during audits and inspections
ALTRION supports representation during audits and inspections carried out by Authorities or Notified Bodies. This service helps manufacturers manage regulatory interactions with better preparation, clearer documentation and a structured communication process.
Through its EU-REP role, ALTRION helps ensure that relevant documentation, communication records and regulatory evidence are available to support inspections or authority reviews.
Registration with the Italian Ministry of Health
Although the registration of medical devices in the Italian Ministry of Health database is no longer generally required for all MDR-compliant devices following the progressive implementation of EUDAMED, specific registration requirements may still apply in certain circumstances, particularly for participation in public procurement procedures, supply to public healthcare institutions, and other national administrative requirements.
As part of its regulatory support services, ALTRION assists manufacturers in assessing whether registration in the Italian national database is required for their specific business activities and intended distribution channels.
Where applicable, ALTRION manages the entire registration process, including:
- Verification of regulatory and product documentation;
- Preparation and submission of device data through the Ministry of Health portal;
- Alignment of UDI and Basic UDI-DI information with MDR requirements;
- Management of updates and amendments to existing registrations;
- Communication of registration confirmations and assigned identification codes.
By providing this support, ALTRION helps manufacturers ensure compliance with applicable Italian national requirements while maintaining consistency with MDR and EUDAMED registration obligations.
FAQ about EU-REP for medical devices
What is an EU-REP?
An EU-REP is a European Authorized Representative appointed by a non-EU manufacturer to act as its official legal interface with EU Competent Authorities, Notified Bodies and EUDAMED.
Who needs an EU-REP?
Non-EU manufacturers that intend to market medical devices or in vitro diagnostic devices in the European Union must appoint an EU-REP under MDR or IVDR.
Does the EU-REP manage EUDAMED registration?
Yes. ALTRION supports both the registration of economic operators and the registration of medical devices within EUDAMED. Our services include Actor Registration and the acquisition of the SRN (Single Registration Number), as well as the preparation, verification and submission of device registration data, including Basic UDI-DI, UDI-DI and other information required under Regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR).
We assist manufacturers throughout the entire EUDAMED registration process, ensuring that economic operator and device information is correctly submitted, maintained and updated in accordance with applicable regulatory requirements.
Does ALTRION review technical documentation?
Yes. ALTRION verifies and continuously monitors the Declaration of Conformity and Technical Documentation in accordance with Annexes II and III of Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR), ensuring that the documentation remains complete, consistent and compliant throughout the product lifecycle.
Can ALTRION help create or complete Technical Documentation?
Yes. Beyond document review, ALTRION can support manufacturers in the preparation, remediation and maintenance of Technical Documentation required for market access under MDR and IVDR. Our team can develop complete technical files from the ground up or assist manufacturers in closing identified gaps where documentation is incomplete, outdated or non-compliant.
Support may include the preparation or review of General Safety and Performance Requirements (GSPR), Risk Management documentation, Clinical Evaluation Reports (CER), Performance Evaluation documentation, PMS and PMCF documentation, labeling and IFU reviews, regulatory strategies, and other elements required by Annexes II and III of MDR and IVDR.
Whether a manufacturer requires a full technical documentation package or targeted support on specific sections, ALTRION provides practical regulatory expertise to facilitate successful market access and ongoing compliance.
Can ALTRION support Italian Ministry of Health registration?
Yes. As part of its EU-REP services, ALTRION manages medical device registration in the Italian Ministry of Health database, including documentation verification, product data upload, UDI and Basic UDI-DI mapping and communication of assigned codes.
Why choose ALTRION
ALTRION provides an EU-based, multilingual regulatory team experienced in MDR and IVDR compliance, with proven experience managing legacy and transition devices from MDD/IVDD to MDR/IVDR. The service includes centralized regulatory document control and secure vigilance tracking, supported by transparent contracts that are renewable annually and have no hidden costs. ALTRION is also part of a global compliance network offering CH-REP services in Switzerland, UKRP services in the United Kingdom and US FDA Agent services for worldwide market access.
Deliverables
ALTRION provides the key regulatory outputs required to formalize EU-REP appointment, support EU compliance and maintain traceability throughout the product lifecycle.
- EU-REP Designation Letter and Service Agreement compliant with MDR/IVDR Article 11.
- EUDAMED registration confirmation, including Actor Registration, SRN issuance and Device Registration support where applicable.
- Confirmation of Italian Ministry of Health registration, where required.
- Contact information for labeling, technical documentation and regulatory communications.
- Technical Documentation review against MDR/IVDR requirements, including Annexes II and III.
- Preparation, remediation or completion of Technical Documentation packages where requested, including GSPR checklists, Risk Management documentation, Clinical Evaluation Reports (CER), Performance Evaluation documentation, PMS/PMCF documentation, labeling and IFU review.
- Regulatory gap assessments and market access strategies for MDR and IVDR compliance.
- Annual PMS and vigilance summary, with full communication log.
- Support in regulatory responses, Competent Authority interactions and CAPA documentation when required.
Depending on the manufacturer’s needs, ALTRION can provide either targeted regulatory support or the development of a complete technical documentation package required for European market access.
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