EUDAMED Consulting

__________

EUDAMED Consulting

Introduction

The European Database on Medical Devices (EUDAMED) was born out of requirements in both the EU Medical Device Regulation 2017/745 (MDR) and the EU IVD Regulation 2017/746 (IVDR) and is made up of the following six modules:

  • Actor Registration.
  • UDI and Device Registration.
  • Notified Bodies and Certificates.
  • Clinical Investigations and Performance Studies.
  • Vigilance and Post-Market Surveillance.
  • Market Surveillance.

Although the registration of actors and UDI/devices remains voluntary, we encourage the use of EUDAMED in order to familiarise yourselves with the processes and requirements related to it from now.

Under the EU MDR and IVDR, you will be obliged to register all devices in EUDAMED. This involves first inputting details of your Basic UDI-DI (BUDI), and then the associated UDI-DI details for all variants or devices falling under that BUDI.

At Specculo, we understand the pivotal role of EUDAMED in ensuring seamless market access for your medical devices within the European Union. Navigating the complexities of EUDAMED registration is crucial for manufacturers, and that’s where our expert services come in. With our dedicated support, you can confidently register your devices and establish a strong presence in the EU market.

Services

1. Actor Registration

We guide manufacturers through the step-by-step process of registering on EUDAMED. Our experts ensure all required information is accurately entered, making the registration process swift and hassle-free.

Alternatively, we can register actors such as manufacturers and importers on the EUDAMED Actor Registration module in order to obtain their Single Registration Number (SRN).

2. Device & UDI-DI Registration

Registering individual medical devices can be intricate and time consuming. Our team streamlines the device registration process, handling all necessary documentation and data entry, ensuring your products are accurately represented in EUDAMED.

3. Data Upload and Management

Managing vast amounts of data can be overwhelming. We assist in organizing and uploading essential information about your devices into EUDAMED, ensuring compliance with EU regulations and standards.

4. Ongoing Compliance Monitoring

EUDAMED requirements evolve, and it’s essential to stay updated. We provide continuous monitoring and updates, ensuring your registrations remain compliant with the latest EU regulations, giving you peace of mind.

Specculo Process

For both the Actor and UDI Registration services, a member of our team will be in touch to request specific information on your organisation or your device.

In the case of Actor Registration, we will input this information, submit the registration application and obtain your Single Registration Number (SRN). The time taken for this process will greatly depend on the EU Competent Authority reviewing the application and, if applicable, your EU Authorised Representative’s processes. At the end of this process, you and another member of your organisation shall be granted with Local Actor Administrator rights.

The registration of your devices on EUDAMED involves a member of our team inputting the required information into the database and submitting the registration. Once submitted, the device is considered to have been registered.

Why Choose Our EUDAMED Registration Services

Expert Guidance: Benefit from the expertise of our professionals well-versed in EUDAMED requirements, ensuring accurate and efficient registration processes.

Timely Registrations: We understand the significance of timelines. Our streamlined approach ensures your registrations are completed promptly, allowing you to access the EU market without unnecessary delays.

Data Accuracy: Accuracy is paramount in EUDAMED registrations. We meticulously review and verify all data, minimizing the risk of errors and ensuring compliance with EU standards.

Comprehensive Support: From initial registration to ongoing compliance updates, we offer comprehensive support, allowing you to focus on your core business while we handle the regulatory intricacies.

Get Started

Secure your foothold in the EU market with our expert EUDAMED registration services. Let Specculo be your trusted partner in navigating the complexities of EUDAMED, ensuring your devices are accurately represented, and your business thrives in the European market. Contact us today to discuss your EUDAMED registration needs and embark on a journey of seamless EU market access.

Your Gateway to EU Market Success Starts Here – Contact Us Today!

What you get with Specculo

We have years of experience in handling large and small projects alike on a vast range of medical devices and IVD technology.

Experience

As your regulatory consultant, you get our full attention throughout the project.

Expertise

You can expect guidance on taking UDI registrations in-house and consultancy on your registration strategy.

Fast lead times

We give you our time and take you through the created documentation, and how to maintain it.​

Simplify your compliance workflow.