MedEnvoy Global
MedEnvoy Global B.V.
End-to-end medical device registration management with proprietary GloRIAS platform for efficient EUDAMED data management and submissions.
About
**MedEnvoy Global** specializes in end-to-end medical device registration management, offering proprietary platform solutions for efficient EUDAMED data management and submissions. They provide expert support for Actor and UDI registration, ensuring compliance with the European Medical Devices Regulation (MDR) and In Vitro Diagnostic Devices Regulation (IVDR).
**Who they are**
MedEnvoy Global is a provider focused on navigating the complexities of medical device regulations in the European market.
**Expertise & scope**
* Facilitates seamless EUDAMED registration and compliance.
* Supports Actor registration, a prerequisite for UDI registration.
* Assists with Device/UDI registration using the dedicated module.
* Covers Actor registrations which require Competent Authority or Notified Body review and approval.
* Advises on the timeline for Actor approvals, which can vary significantly.
* Helps acquire UDI and European Medical Device Nomenclature (EMDN) codes.
* Ensures requisite device details and characteristics are available for registration.
**Reputation / proof points**
* Offers services across the EU.
* Supports multiple languages including English, Dutch, German, and French.
**Who they are**
MedEnvoy Global is a provider focused on navigating the complexities of medical device regulations in the European market.
**Expertise & scope**
* Facilitates seamless EUDAMED registration and compliance.
* Supports Actor registration, a prerequisite for UDI registration.
* Assists with Device/UDI registration using the dedicated module.
* Covers Actor registrations which require Competent Authority or Notified Body review and approval.
* Advises on the timeline for Actor approvals, which can vary significantly.
* Helps acquire UDI and European Medical Device Nomenclature (EMDN) codes.
* Ensures requisite device details and characteristics are available for registration.
**Reputation / proof points**
* Offers services across the EU.
* Supports multiple languages including English, Dutch, German, and French.
Additional information
Manufacturers are required to register as an Actor in EUDAMED before proceeding with UDI registrations. Actor registrations undergo a review and approval process by Competent Authorities or Notified Bodies, which can lead to delays as the mandatory EUDAMED usage date approaches. MedEnvoy Global emphasizes planning Actor registrations well in advance to avoid compliance issues. Once the Actor registration is active, the Device/UDI registration module can be utilized. While UDI registrations do not require approval, they can be time-consuming, particularly for companies with extensive device portfolios. This includes acquiring necessary UDI and EMDN codes and having all required device information readily accessible.
Key Highlights
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Provides end-to-end medical device registration management.
Source
“End-to-end medical device registration management with proprietary GloRIAS platform for efficient EUDAMED data management and submissions.”
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Offers expert support for EUDAMED Actor and UDI registration under MDR and IVDR.
Source
“Ensure seamless EUDAMED registration and compliance with expert support for Actor and UDI registration under MDR and IVDR.”
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Covers EUDAMED registration requirements and timelines for manufacturers.
Source
“EUDAMED Registration Requirements and Timeline for Manufacturers”
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Facilitates the acquisition of UDI and European Medical Device Nomenclature (EMDN) codes.
Source
“You will need to acquire UDI and European Medical Device Nomenclature (EMDN) codes for each device...”
Certifications & Trust Signals
Buyer Snapshot
Best for
- Manufacturers needing assistance with EUDAMED Actor and UDI registration.
- Companies seeking to ensure MDR and IVDR compliance.
- Organizations requiring support with device data management for European submissions.
How engagement typically works
- Expert-led guidance for regulatory processes.
- Platform-based solutions for data management.
- Proactive planning and timeline management.
Typical deliverables
- Completed EUDAMED Actor registration.
- Completed EUDAMED UDI/Device registration.
- Guidance on acquiring UDI and EMDN codes.
- Support with device data compilation for submissions.
Good to know
- Best when proactive planning for Actor registration timelines is prioritized.
HQ:
Den Haag, NL
Languages:
English, Dutch, German, French
Timezones:
CET, GMT
Status:
listed
Services & Capabilities
EUDAMED Onboarding & Data Registration Support (Mandatory Modules)
Jurisdictions:
EU
Countries:
Netherlands, Germany, France, UK
Industries:
Medical Devices, IVD
Pricing model:
Retainer
Modules Supported:
Actor/SRN, UDI/Devices
Submission Approach:
Portal, Bulk Submissions
Portfolio Fit:
100+
Onboarding Speed:
6+ weeks
Managed Service Available:
Yes
Integration Support:
ERP/PLM mapping, Labeling mapping
Additional eudamed_onboarding_support Details
Modules Supported
Actor, UDI/Devices
Submission Approach
Portal operations
