As cell and gene therapies continue to transform the treatment of blood cancers, rare diseases, and other life-threatening conditions, ensuring the safety, quality, and traceability of the products supporting these therapies has never been more important.

From cell collection and processing to cryopreservation, storage, transportation, and final administration, advanced therapies rely on a complex system of medical devices, healthcare providers, manufacturers, distributors, and regulatory authorities working together across international borders. As these therapies expand throughout Europe, maintaining visibility across the supply chain is becoming increasingly important to protecting patients and supporting regulatory compliance.

A major milestone toward this goal occurred on May 28, 2026, when key modules of the European Database on Medical Devices (EUDAMED) became mandatory under the European Union Medical Device Regulation (EU MDR). EUDAMED is the European Commission’s centralized medical device database, designed to improve visibility, traceability, and regulatory oversight across all EU Member States.

What is EUDAMED?

EUDAMED is a comprehensive digital system that consolidates important medical device information into a single platform. 

The database includes:

• Economic Operator (Actor) registration
• Medical device registration
• Unique Device Identification (UDI) information
• Certificates issued by Notified Bodies
• Market surveillance and vigilance activities
• Regulatory compliance data

Historically, medical device manufacturers and other economic operators navigated separate national registration systems and competent authorities. EUDAMED now provides one centralized platform for Actor registration, device registration, certificates, market surveillance activities, and UDI information. Bringing this information together into a single system gives manufacturers, regulators, and other economic operators a more consistent way to manage regulatory information, while improving transparency throughout the medical device lifecycle.

The Importance of Single Registration Numbers (SRNs)

As part of the EU MDR, manufacturers and other economic operators must obtain a Single Registration Number (SRN), a unique identifier recognized across all EU Member States that establishes their identity within EUDAMED. The SRN supports consistent regulatory oversight while simplifying interactions with competent authorities.

OriGen Biomedical has completed its EUDAMED Actor registration and has been assigned SRN US-MF-000018098. Additionally, OriGen has completed EUDAMED registration activities for all applicable legacy devices that continue to be marketed within the EU, supporting continued compliance with evolving EU MDR requirements.

Why EUDAMED Matters for Cell and Gene Therapy

While regulatory systems like EUDAMED operate largely behind the scenes, their impact extends throughout the patient journey. The advanced therapy supply chain relies on specialized medical devices that collect, process, preserve, transport, and deliver life-saving cellular materials. Strengthening traceability across these products allows regulators to verify manufacturers, confirm certifications, monitor safety, and respond more efficiently when needed, helping support the patients who depend on these therapies.

Greater transparency and harmonized oversight also reduce administrative complexity across EU Member States, supporting more efficient market access and allowing innovative technologies to reach clinicians and patients with fewer regulatory barriers. For organizations developing advanced therapies, this creates a more predictable regulatory environment. For clinicians, it strengthens confidence in the medical devices supporting patient care. For patients and their families, it reinforces the systems working behind the scenes to promote safety, quality, and continued access to innovative treatments that support their care.

What this Means for OriGen Biomedical Customers

For OriGen customers, EUDAMED registration demonstrates an ongoing commitment to transparency, compliance, and uninterrupted access to critical products.

By proactively completing EUDAMED registration activities, OriGen helps customers:

• Maintain Confidence in Regulatory Compliance: Customers can be assured that OriGen’s devices are properly registered and aligned with EU MDR requirements, reducing regulatory uncertainty when supporting clinical and commercial cell and gene therapy programs.
• Support Supply Chain Transparency: EUDAMED provides a centralized source of regulatory information, making it easier for stakeholders to verify manufacturer registration, device information, and regulatory status.
• Enable Continued Access to Critical Products: By registering devices and legacy products in a timely manner, OriGen helps ensure continued product availability in the European market, minimizing disruption for customers supporting patient therapies.
• Strengthen Quality and Traceability: Enhanced traceability supports greater visibility throughout the medical device lifecycle, helping customers meet their own quality, documentation, and regulatory obligations.

Supporting the Future of Advanced Therapies

As cell and gene therapies continue to evolve, regulatory systems must evolve alongside them. EUDAMED represents an important step toward a more connected, transparent, and efficient regulatory framework for medical devices across Europe. OriGen Biomedical’s regulatory excellence extends beyond compliance. By embracing initiatives such as EUDAMED and proactively meeting evolving EU MDR requirements, we help create a stronger foundation for our customers, support clinicians delivering innovative therapies, and contribute to the safe advancement of cell and gene therapy worldwide.

As a trusted partner to the advanced therapy community, OriGen remains committed to delivering high-quality products, maintaining regulatory leadership, and supporting the patients whose lives depend on these treatments every day. We also believe that advancing healthcare requires ongoing collaboration and knowledge sharing. Through our News & Insights platform, we provide information on regulatory developments and community initiatives.

About the Author

Carissa Bishop

Regulatory Affairs Project Manager

Carissa specializes in global medical device regulatory affairs, quality systems, and market access strategy. She leads OriGen’s international regulatory submissions, EU MDR implementation, FDA and Health Canada regulatory activities, global product registrations, manufacturing site transitions, product lifecycle management, and design change initiatives. She partners closely with quality, engineering, operations, marketing, and commercial teams to translate complex regulatory requirements into practical, risk-based solutions that accelerate market access, maintain compliance, and support the delivery of safe, effective medical devices to patients worldwide.

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