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 is a consultancy firm with over 10 years of experience in the Medical Device and Pharmaceutical Industries, dedicated to assisting companies in navigating the European Databank on Medical Devices (EUDAMED).
**Expertise & scope**
* Expert guidance on EUDAMED Actor Registration, including understanding actor roles and the Single Registration Number (SRN).
* Support for UDI/Device Registration, helping manufacturers submit required device information.
* Assistance with the Notified Bodies & Certificates Module, including the registration of certificates and related data.
* Consultancy services for Medical Devices Regulation (MDR) and In Vitro Devices Regulation (IVDR) procedures.
* Offers remote and face-to-face consulting.
**Reputation / proof points**
* Over 10 years of experience in Medical Device and Pharmaceutical Industries.
EUDAMED Medical Consulting is a consultancy firm with over 10 years of experience in the Medical Device and Pharmaceutical Industries, dedicated to assisting companies in navigating the European Databank on Medical Devices (EUDAMED).
**Expertise & scope**
* Expert guidance on EUDAMED Actor Registration, including understanding actor roles and the Single Registration Number (SRN).
* Support for UDI/Device Registration, helping manufacturers submit required device information.
* Assistance with the Notified Bodies & Certificates Module, including the registration of certificates and related data.
* Consultancy services for Medical Devices Regulation (MDR) and In Vitro Devices Regulation (IVDR) procedures.
* Offers remote and face-to-face consulting.
**Reputation / proof points**
* Over 10 years of experience in Medical Device and Pharmaceutical Industries.
Additional information
EUDAMED Medical Consulting focuses on key EUDAMED modules essential for medical device compliance within the EU. Their services cover Actor Registration, UDI/Device Registration, and the Notified Bodies & Certificates Module. They emphasize their role in helping companies manage these complex EUDAMED processes. Buyers should note that while some modules are available for voluntary use, the mandatory use of certain modules is tied to transition periods outlined in Regulation (EU) 2024/1860. This means additional national requirements may apply. Engagement typically involves expert guidance to ensure accurate and compliant submissions.
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 services for Medical Devices Regulation (MDR) and In Vitro 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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Focuses on EUDAMED, a key aspect of new EU regulations for medical and in-vitro diagnostic devices.
Source
“The creation of a European Database on Medical devices (EUDAMED) is one of the key aspects of the new rules on Medical Devices Regulation (EU) 2017/745 and In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746.”
Buyer Snapshot
Best for
- Companies needing to register as actors in EUDAMED.
- Manufacturers preparing for UDI/Device registration.
- Organizations requiring support with Notified Body certificate submissions.
How engagement typically works
- Direct consultancy and guidance.
- Remote and face-to-face support options.
Typical deliverables
- Assistance with Actor Registration process and SRN acquisition.
- Support for UDI/Device data submission.
- Guidance on Notified Body certificate registration.
- MDR and IVDR compliance consulting.
Good to know
- Best when engaging with EUDAMED requirements for medical devices and in-vitro diagnostic devices within the EU.
HQ:
Brussels, EU
Languages:
English, French
Timezones:
Europe/Brussels
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
true
Supports UDI
true
Supports Vigilance
false
Supports Clinical Investigations
false
