REGULATORY AND QUALITY

The European Database on Medical Devices (EUDAMED) is becoming a key pillar of the European regulatory framework under Regulation (EU) 2017/745 (MDR). Following the gradual implementation of Regulation (EU) 2024/1860, Actor Registration and UDI/Device Registration in EUDAMED became mandatory from 28 May 2026. Consequently, manufacturers and other economic operators placing MDR CE-marked medical devices on the European market are required to register the relevant information in EUDAMED.

For legacy devices that continue to be placed on the market under the transitional provisions of the MDR, the legislation provides an additional transition period. These devices must be registered in EUDAMED by 28 November 2026.

Navigating these regulatory requirements can be challenging, particularly for companies managing extensive product portfolios or entering the European market for the first time. Our dedicated EUDAMED Registration Service is designed to support manufacturers, authorised representatives, importers, and other economic operators in fulfilling their obligations efficiently and accurately.

Whether you require expert guidance throughout the registration process or prefer to outsource the entire activity, our experienced Regulatory Affairs team can provide a tailored solution tailored to your specific needs.

We offer comprehensive support for EUDAMED registration activities, including:

• Assessment of your EUDAMED registration requirements under the MDR
• Assistance with the registration of economic operators and acquisition of the Single Registration Number (SRN)
• Review and creation of Basic UDI-DI and UDI-DI codes in accordance with the MDR and the applicable issuing entity rules (GS1, HIBCC or ICCBBA), ensuring a robust and compliant UDI strategy prior to EUDAMED registration
• Support in defining UDI structures for new product portfolios and reviewing existing UDI assignments for regulatory compliance
• Registrations in the applicable EUDAMED modules
• Preparation and review of the required documentation and technical information
• Liaison with Competent Authorities, where required, to facilitate the registration process
• Ongoing support for updates, corrections and maintenance of EUDAMED records throughout the device lifecycle

Our Regulatory Affairs specialists have extensive experience in European medical device legislation, UDI implementation and EUDAMED registration. We support manufacturers across a broad range of medical device technologies and risk classes, combining in-depth regulatory expertise with practical project management to ensure an efficient, timely and compliant registration process.

By partnering with us, you can:

• Reduce the administrative burden associated with EUDAMED and UDI management
• Minimise the risk of submission errors and regulatory delays
• Ensure compliance with MDR requirements and evolving European regulatory expectations
• Implement a consistent and compliant UDI strategy across your product portfolio

Whether you are preparing your first MDR registration, managing a large device portfolio or updating existing registrations, Donawa Lifescience provides flexible support that can range from targeted consultancy to complete management of your EUDAMED and UDI activities.