Ministry Registrations
and EUDAMED

EUDAMED (European Database on Medical Devices) is the European database for medical devices and in vitro diagnostic medical devices (IVDs), developed by the European Commission to enhance traceability, transparency, and market surveillance across the European Union.

The platform includes several interconnected modules covering:

• registrazione operatori economici
• registrazione dispositivi
• UDI/UDI-DI
• organismi notificati e certificati
• vigilanza e sorveglianza post-market
• indagini cliniche e performance studies

The use of EUDAMED is a key component of MDR and IVDR compliance for manufacturers, importers, authorised representatives, and other economic operators, supporting regulatory transparency and facilitating the exchange of information between stakeholders and competent authorities.

Economic Operator Registration

We support companies and economic operators in completing EUDAMED registration in accordance with MDR and IVDR requirements.

Our services may include:

• Manufacturer registration
• Support with Single Registration Number (SRN) applications
• Authorised Representative registration
• Importer registration
• Verification of company and supporting documentation data
• Operational support throughout the validation process

Medical Device and IVD Registration

TentaConsult Italia assists companies in managing the information required for the registration of medical devices and IVDs within EUDAMED.

Our activities include:

• Device data submission
• UDI-DI management support
• Technical documentation consistency review
• MDR/IVDR classification support
• Management of regulatory updates
• Verification of compliance with EUDAMED data requirements

UDI Management and Device Traceability

The Unique Device Identification (UDI) system is one of the key requirements introduced by the MDR and IVDR to ensure the identification and traceability of medical devices throughout their lifecycle.

We support companies in:

• Defining UDI implementation strategies
• Managing UDI-DI codes
• Verifying labeling compliance
• Integrating regulatory information
• Aligning technical documentation with EUDAMED requirements and records

The MDR and IVDR have introduced more stringent requirements for traceability, data management, and market surveillance throughout the product lifecycle.

Incomplete or inaccurate registration management may result in:

• Delays in market access and product commercialization
• Issues during audits and regulatory inspections
• Documentation inconsistencies
• UDI management challenges
• Regulatory non-compliance

TentaConsult Italia supports companies in the coordinated management of regulatory activities, ensuring alignment between technical documentation, CE marking requirements, and official registrations.

Our Process

1. Preliminary Assessment
   We review the device’s regulatory status, available documentation, and applicable regulatory obligations.
2. Regulatory Strategy Definition
   We identify the required registrations and develop a structured plan for regulatory implementation.
3. EUDAMED and National Registration Support
   We provide assistance with data collection, documentation review, and the management of EUDAMED and national registration activities.
4. MDR/IVDR Compliance Verification
   We verify consistency between registrations, technical documentation, and applicable regulatory requirements.
5. Ongoing Maintenance and Updates
   We provide continuous support for regulatory updates, data changes, and long-term compliance management.

Do you need support with EUDAMED or national registrations?

TentaConsult Italia supports manufacturers, importers, and distributors in managing MDR and IVDR regulatory obligations, including EUDAMED registrations, national registration requirements, and ongoing compliance activities.