EUDAMED Medical Consulting
EUDAMED Medical Consulting offers expert guidance on navigating the EUDAMED database for medical devices and in-vitro diagnostic devices. They specialize in Actor Registration, UDI/Device Registration, and Notified Bodies & Certificates Module.
EUDAMED Medical Consulting is a specialized provider assisting companies with the complexities of the European Databank On Medical Devices (EUDAMED). They offer comprehensive support for crucial EUDAMED modules, including Actor Registration, UDI/Device Registration, and the Notified Bodies and Certificates Module. Their expertise ensures compliance with Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). They help clients manage EUDAMED processes, ensuring accurate registration of devices, economic operators, and relevant documentation. Whether you are a manufacturer, importer, or authorized representative, EUDAMED Medical Consulting provides the necessary guidance to successfully integrate with the EUDAMED system, enhancing transparency and coordination within the EU market.
About
**Who they are**
EUDAMED Medical Consulting provides expert guidance for navigating the EUDAMED database, specializing in medical and in-vitro diagnostic devices. With over 10 years of experience in the medical device and pharmaceutical industries, they offer comprehensive consultancy services.
**Expertise & scope**
* Implementation of MDR (Medical Devices Regulation) and IVDR (In-Vitro Devices Regulation) procedures.
* Support for EUDAMED processes, including Actor Registration, UDI/Devices Registration, and the Notified Bodies & Certificates Module.
* Guidance on Actor Registration, including understanding the seven distinct actor roles and the Single Registration Number (SRN).
* Assistance with UDI/Device registration, including the submission of device information and understanding requirements for legacy devices.
* Support for the Notified Bodies & Certificates Module, including registration of certificates and Summaries of Safety and Clinical Performance.
**Reputation / proof points**
* Over 10 years of experience in the Medical Device and Pharmaceutical Industries.
EUDAMED Medical Consulting provides expert guidance for navigating the EUDAMED database, specializing in medical and in-vitro diagnostic devices. With over 10 years of experience in the medical device and pharmaceutical industries, they offer comprehensive consultancy services.
**Expertise & scope**
* Implementation of MDR (Medical Devices Regulation) and IVDR (In-Vitro Devices Regulation) procedures.
* Support for EUDAMED processes, including Actor Registration, UDI/Devices Registration, and the Notified Bodies & Certificates Module.
* Guidance on Actor Registration, including understanding the seven distinct actor roles and the Single Registration Number (SRN).
* Assistance with UDI/Device registration, including the submission of device information and understanding requirements for legacy devices.
* Support for the Notified Bodies & Certificates Module, including registration of certificates and Summaries of Safety and Clinical Performance.
**Reputation / proof points**
* Over 10 years of experience in the Medical Device and Pharmaceutical Industries.
Additional information
EUDAMED Medical Consulting assists companies in managing complex EUDAMED processes. They emphasize their role in helping clients navigate the Actor Registration, UDI/Device Registration, and Notified Bodies & Certificates modules. Their services are designed to ensure compliance with MDR and IVDR regulations, providing support for both manufacturers and other economic operators. Clients can expect guidance on specific EUDAMED functionalities and regulatory requirements.
Key Highlights
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Offers expert guidance on EUDAMED Actor Registration, UDI/Devices Registration, and Notified Bodies & Certificates Module.
Source
“EUDAMED Medical Consultancy is always ready to help you manage EUDAMED processes on behalf of your company and the products you manufacture / import.”
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Provides consultancy for Medical Devices Regulation (MDR) and In Vitro Diagnostic Devices Regulation (IVDR).
Source
“Our goal as a consulting company is to provide a wide range of consultancy services to medical device companies such as, implementation of MDR (Medical Devices Regulation), IVDR (In-Vitro Devices Regulation) and EUDAMED (European Databank On Medical Devices) procedures.”
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Has over 10 years of experience in the Medical Device and Pharmaceutical Industries.
Source
“EUDAMED Medical Consulting has experience over 10 years in Medical Device and Pharmaceutical Industries.”
Certifications & Trust Signals
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The Actor Registration Module is the first publicly accessible part of EUDAMED, and this provider offers support for it.
Source
“The Actor Registration Module is the first publicly accessible part of EUDAMED, the European database for medical devices.”
Buyer Snapshot
Best for
- Companies needing assistance with EUDAMED Actor Registration.
- Manufacturers requiring support for UDI/Device registration.
- Organizations seeking guidance on the Notified Bodies & Certificates Module.
How engagement typically works
- Remote and face-to-face consulting services.
- Expert guidance and knowledge contribution to client success.
Typical deliverables
- Assistance with Actor Registration and SRN validation.
- Support for UDI/Device information submission.
- Guidance on Notified Body certificate registration.
- MDR and IVDR compliance consultancy.
Good to know
- Best when clients require specialized support for EUDAMED modules and MDR/IVDR compliance.
HQ:
Brussels, EU
Languages:
English, French
Timezones:
Europe/Brussels
Claim status:
Listed
Services & Capabilities
Best EUDAMED Registration| Compare & Get Quotes
Jurisdictions:
EU
Countries:
FR, DE, AT, PL, IT, SE
Industries:
Medical devices, IVD, SaMD, Manufacturing
Portfolio:
6-25
Onboarding time:
5–30 days
Pricing model:
Custom pricing
Starting from:
EUR 1,800
Included services:
Actor/SRN registration support, UDI/Device module readiness, Data preparation & validation, Training enablement
Supports Actor Registration:
Yes
Supports UDI:
Yes
Supports Data Load:
Yes
Modules Supported:
Actor/SRN, UDI/Devices, Certificates
Supports Training Enablement:
No
Data Load Support Level:
Done-for-you
Turnaround SLA:
Custom
eudamed_onboarding_support
Additional eudamed_reg_support Details
Included Services Detailed
Actor/SRN registration readiness review and submission support (seed scope), UDI/Device data preparation, validation, and upload workflow support (seed scope), Internal data governance mapping (roles, owners, approvals) (seed scope), Training enablement for EUDAMED operational tasks (seed scope)
Excluded Services
Notified Body services or conformity assessment decision-making, Legal representation with Competent Authorities, Clinical evaluation or performance evaluation writing (unless separately scoped)
Onboarding Steps
The website content does not detail specific onboarding steps, required documents, timelines, or setup procedures.
Data Load Notes
Data load support level indicates whether uploads are done-for-you, guided, or training-only (seed summary).
Modules Supported
Actor Registration, UDI/Devices Registration, Notified Bodies and Certificates Module
Supports Actor Registration
Yes
Supports UDI
Yes
Supports Vigilance
No
Supports Clinical Investigations
No
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