EUDAMED Registration Consultants

In the evolving regulatory landscape of the European Union, the European Database on Medical Devices (EUDAMED) plays a crucial role in ensuring the safety and transparency of medical devices. For manufacturers aiming to market their medical devices in the EU, understanding and complying with EUDAMED requirements is essential.

We offer comprehensive EUDAMED registration services to help you navigate this complex process, ensuring your products meet all necessary regulatory standards for successful market entry.

Objectives of EUDAMED:

  • It enables better access to information for the public and healthcare professionals, also enhancing coordination between member states in the European Union [EU].
  • Meets the requirements mentioned in EU MDR 2017/745 and EU IVDR 2017/746.
  • To provide a living picture of the Lifecycle of medical devices that are made available in the European Union.
  • To integrate different electronic systems to collate and process information about medical devices and related stakeholders(companies, manufacturers)
  • Foster collaboration between different stakeholders including the public, with an emphasis on public safety and clinical evidence.

Modules of EUDAMED:

The EUDAMED is structured around 6 interconnected modules and a public website:

  • Actors Registration
  • UDI (Unique Device Identification) / Devices Registration
  • Notified Bodies and Certificates
  • Clinical Investigations and Performance Studies
  • Vigilance
  • Market Surveillance

Currently, the first three components are active. The manufacturer should register first as an actor and then proceed to device registration.To register, manufacturers need to create an account and accurately fill in the required information.

What Makes an EU MDR Authorized Representative Vital for Medical Device Companies?

When you’re a medical device manufacturer outside the EU, entering the European market can feel like navigating a maze of red tape and strict regulations. That’s where having an EU MDR Authorized Representative becomes a game-changer. Without one, your products simply won’t make it to market. With the right partner, though, compliance becomes smoother, risks shrink, and you get the peace of mind you need to focus on what matters most: building great medical devices.

This is exactly where Cert3Global steps in. As a trusted partner, Cert3Global ensures that manufacturers like you can access the EU market with confidence, while staying fully compliant with the latest rules and requirements.

 

Why an EU MDR Authorized Representative Is Non-Negotiable

The EU MDR (Medical Device Regulation) introduced stricter rules to protect patients and improve transparency. If you’re not based in the EU, you must legally appoint an EU MDR Authorized Representative to act as your official contact point. This representative is more than just a formality; it’s your ticket to compliance.

Cert3Global takes on this responsibility with unmatched professionalism. By partnering with them, you get more than just a name on paper—you gain a knowledgeable, proactive team that makes sure your company stays in line with regulations.

 

Key Responsibilities Handled by Cert3Global

Some of the critical roles they manage include:

  • Acting as your official EU-based contact for regulators and authorities.
  • Ensuring all your product documentation and technical files are maintained correctly.
  • Keeping you informed about regulatory updates and changes.
  • Managing incident reports and communication with EU authorities when required.

Each of these roles is vital, and Cert3Global does them all with precision and care, helping you avoid costly delays or penalties.

 

The Link Between Authorized Representation and EUDAMED

The new EU database, EUDAMED, adds another layer of responsibility. To sell in the EU, your company’s data and product details must be properly registered here. Without accurate registration, your devices won’t be legally recognized.

This is where EUDAMED compliance services come into play. By managing both representation and database compliance under one roof, Cert3Global saves you from juggling multiple service providers.

 

Benefits of Partnering with Cert3Global

Working with Cert3Global gives your business more than just compliance—it gives you a competitive edge. Some of the biggest benefits include:

  • Market Access Without Delays: Smooth entry into the EU market without last-minute surprises.
  • Expert Regulatory Guidance: Clear explanations and proactive support so you always know where you stand.
  • Risk Reduction: Lower chances of non-compliance, which can lead to fines or product withdrawal.
  • Reputation Protection: Demonstrating to EU regulators and buyers that you meet the highest standards.
  • End-to-End Support: From paperwork to EUDAMED, everything is managed under one trusted partner.

With Cert3Global, you don’t just tick boxes; you build a solid foundation for long-term growth in Europe.

 

Why Cert3Global Stands Out

Plenty of firms claim to offer representation services, but Cert3Global is in a league of its own. Here’s why they’re the best fit for medical device manufacturers:

  • A hands-on approach that blends technical expertise with personal support.
  • Comprehensive service packages, including both EU MDR Authorized Representative duties and EUDAMED compliance services.

With Cert3Global, you’re not treated like just another client; you’re a valued partner.

Additional Information

Understanding EUDAMED and Its Importance

EUDAMED is a centralized database designed to enhance the overall transparency and traceability of medical devices in the European market. It is part of the EU’s Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) framework. EUDAMED integrates several interconnected modules, including:

  • Actor Registration: Information about economic operators, including manufacturers, authorized representatives, importers, and distributors.
  • UDI/Device Registration: Details about unique device identification (UDI) and specific device information.
  • Notified Bodies and Certificates: Information on conformity assessment bodies and the certificates they issue.
  • Clinical Investigations and Performance Studies: Data on clinical investigations and performance studies conducted within the EU.
  • Vigilance and Post-Market Surveillance: Reports on adverse events, field safety corrective actions, and post-market surveillance activities.
  • Market Surveillance: Information on market surveillance activities conducted by member states.

EUDAMED aims to improve regulatory oversight, facilitate information exchange among stakeholders, and enhance patient safety by providing comprehensive data on medical devices available in the EU market.

Who Must Register for EUDAMED?

    • Economic Operators (Manufacturers, Authorised Representatives, System and Procedure Pack producers, and importers) are those based in or outside the European Union. If they are involved in selling products into the EU Market or using the CE Mark.

Important Numbers & Code Relevant to EUDAMED

  • SRN Number : as soon as the competent authority has accepted the actor registration, each actor receives an SRN (or actor ID). It is composed of first the country code, like “BE” for Belgium followed by the Actor role abbreviation (like “MF” for the manufacturer) and nine digits.
  • EMDN (European Medical Devices Nomenclature) : they are codes that group medical devices in sets of terms or nomenclatures and are important to register in EUDAMED.
  • Basic UDI-DI : They are a set of codes that group the medical device with the same intended purpose, risk class, and essential design & manufacturing characteristics.By contrast to UDI-DI,the Basic UDI-DI does not appear on the labels of devices.

Steps to Register at EUDAMED:

After the technical documentation has been compiled and the EU Authorization Representative has been appointed (if required), the manufacturer may start the registration process. This process:

  • is for all risk classes of medical devices and IVDs in the EU Markets
  • Should be completed before the appointment of the Notified Body for assessment of conformity assessment procedure, as applicable.

Step1 : Basic UDI-DI and UDIs Issuing Entities (designated by the EU Commission ) such as IFA GmbH, GS1 AISBL, Health Industry Business Communications Council, and ICCBA give the basic UDI-DI and UDIs respectively.

Step2 : Registration of EU Representatives, Manufacturers and Importers

  • Economic operators must register themselves in the Actor Registration Module where information regarding them and their device must be entered.
  • After verification of the information entered, the Authority will issue (to Economic Operators)  an SRN (Single Registration Number) from the Electronic system.
  • This SRN can be used by manufacturer for applying to notified body for conformity assessment.

Step3 : Registration of Devices
In the device registration modules, basic UDI-DI is entered followed by other information related to the medical device (like quantity per package, name, address of manufacturer and SRN, and member state information. For low-risk Medical devices and In Vitro Diagnostics, followed by the registration process, As per guidelines, the EU Declaration of Conformity needs to be prepared for the market launch. For high-risk Medical devices, the notified body‘s involvement is essential for conformity assessments. The manufacturer should prepare the EU declaration of conformity (upon the audit approval for CE Marking ) for market launch.
If you need guidance specially crafted for your medical device, then you can contact us with your query. Our team of experienced regulatory experts will help you in increasing market access to your products in the European Market.

Why Choose Us?

  • Expert Knowledge: Our team has extensive experience in EU regulatory compliance and a deep understanding of EUDAMED requirements.
  • Tailored Solutions: We provide customized services to meet the unique needs of your organization and products.
  • Comprehensive Support: From initial registration to post-market activities, we offer end-to-end support for all aspects of EUDAMED compliance.
  • Efficiency and Accuracy: Our streamlined processes ensure accurate data submission and minimize delays, facilitating timely market access.

Why do I need an EU MDR Authorized Representative if my company is outside the EU?

Because EU law requires it. Without one, your medical devices can’t legally be marketed or sold in the EU.

What exactly does an EU MDR Authorized Representative do?

They act as your official contact in the EU, manage documentation, and ensure your devices comply with MDR requirements.

How does EUDAMED compliance affect my company?

All non-EU manufacturers must register their devices in the EUDAMED database. It ensures transparency and regulatory oversight.

Can Cert3Global handle both representation and EUDAMED compliance?

Yes. Cert3Global provides a full-service package covering both, so you don’t have to work with multiple providers.

What happens if I don’t comply with MDR or EUDAMED requirements?

Non-compliance can result in heavy fines, product recalls, or even being barred from the EU market.

Why should I choose Cert3Global over other service providers?

Because Cert3Global combines deep expertise, personalized support, and a proven track record, it ensures you stay compliant while building trust in the EU market.

Conclusion

Breaking into the EU medical device market is no small feat, but it doesn’t have to be overwhelming. The right EU MDR Authorized Representative makes all the difference between a stressful, uncertain process and a smooth, confident launch. By choosing Cert3Global, you’re not only meeting legal obligations, you’re setting your business up for success in one of the world’s most demanding markets.

When compliance matters as much as your reputation, trust Cert3Global to keep you ahead of the curve.