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 specialized consultancy focused on guiding medical device and in-vitro diagnostic device companies through the European Databank on Medical Devices (EUDAMED) registration processes. With over 10 years of experience in the medical device and pharmaceutical industries, they offer expert support to ensure compliance with MDR (Medical Devices Regulation) and IVDR (In-Vitro Devices Regulation).
**Expertise & scope**
* **EUDAMED Module Support:** Expertise in Actor Registration, UDI/Devices Registration, and the Notified Bodies & Certificates Module.
* **Regulatory Navigation:** Assistance with MDR (EU) 2017/745 and IVDR (EU) 2017/746 requirements related to EUDAMED.
* **Actor Registration:** Guidance on the Actor Registration Module, including understanding actor roles and obtaining Single Registration Numbers (SRNs).
* **UDI/Device Registration:** Support for submitting UDI/Device information for devices placed on the EU market, including legacy devices.
* **Notified Bodies & Certificates:** Assistance with Notified Bodies registering certificate information and Summaries of Safety and Clinical Performance (SSCP).
* **Coverage:** Services are focused on the European Union (EU).
**Reputation / proof points**
* Over 10 years of experience in the Medical Device and Pharmaceutical Industries.
EUDAMED Medical Consulting is a specialized consultancy focused on guiding medical device and in-vitro diagnostic device companies through the European Databank on Medical Devices (EUDAMED) registration processes. With over 10 years of experience in the medical device and pharmaceutical industries, they offer expert support to ensure compliance with MDR (Medical Devices Regulation) and IVDR (In-Vitro Devices Regulation).
**Expertise & scope**
* **EUDAMED Module Support:** Expertise in Actor Registration, UDI/Devices Registration, and the Notified Bodies & Certificates Module.
* **Regulatory Navigation:** Assistance with MDR (EU) 2017/745 and IVDR (EU) 2017/746 requirements related to EUDAMED.
* **Actor Registration:** Guidance on the Actor Registration Module, including understanding actor roles and obtaining Single Registration Numbers (SRNs).
* **UDI/Device Registration:** Support for submitting UDI/Device information for devices placed on the EU market, including legacy devices.
* **Notified Bodies & Certificates:** Assistance with Notified Bodies registering certificate information and Summaries of Safety and Clinical Performance (SSCP).
* **Coverage:** Services are focused on the European Union (EU).
**Reputation / proof points**
* Over 10 years of experience in the Medical Device and Pharmaceutical Industries.
Additional information
EUDAMED Medical Consulting provides direct support for managing EUDAMED processes on behalf of companies and their manufactured or imported products. Their services are designed to help clients navigate the complexities of EUDAMED, ensuring accurate and timely submissions for critical modules. They emphasize their readiness to assist with Actor Registration, UDI/Device Registration, and Notified Bodies & Certificates Module processes, aiming to enhance transparency and coordination within the EU market for medical devices. Companies seeking to understand and implement EUDAMED requirements can leverage their expertise to manage these essential regulatory tasks.
Key Highlights
-
Offers expert guidance on EUDAMED Actor Registration, UDI/Device Registration, and Notified Bodies & Certificates Module.
Source
“EUDAMED will be composed of six modules related to: actor registration, unique device identification (UDI) and device registration, notified bodies and certificates, clinical investigations and performance studies, vigilance and market surveillance.”
-
Provides consultancy services for MDR and IVDR regulations concerning EUDAMED.
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.”
-
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
-
Specializes in EUDAMED, MDR, and IVDR regulations.
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 assistance with EUDAMED Actor Registration.
- Manufacturers requiring support for UDI/Device Registration.
- Organizations navigating Notified Body certificate submissions in EUDAMED.
How engagement typically works
- Direct consultancy and process management.
- Remote and face-to-face consulting services.
Typical deliverables
- Guidance on EUDAMED module requirements.
- Assistance with SRN acquisition.
- Support for UDI/Device data submission.
- Help with Notified Body certificate registration.
Good to know
- Best when requiring specialized EUDAMED registration support within the EU.
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 processes.
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 & Certificates Module
Supports Actor Registration
Yes
Supports UDI
Yes
Supports Vigilance
No
Supports Clinical Investigations
No
⚡ Instant booking available
Book EU EUDAMED Actor & UDI Setup Support
Compare EUDAMED Medical Consulting and other vetted providers — instant pricing, no RFQ needed.
