SistemIR
Sistemir EU S.r.l.
Sistemir provides expert consultancy for CE marking of medical devices, focusing on European regulations, UDI implementation, and Eudamed registration. They assist manufacturers, importers, and other economic operators in navigating complex regulatory requirements.
Sistemir specializes in European medical device regulations, offering comprehensive consultancy for CE marking and compliance with MDR and IVDR. With extensive experience since 2011, they assist clients with all aspects of regulatory affairs, including technical documentation, quality management systems (ISO 13485, MDSAP), and UDI implementation. A key area of expertise is Eudamed registration, where Sistemir guides economic operators (manufacturers, authorized representatives, importers) through the process of obtaining their Single Registration Number (SRN) and registering devices. They offer tailored support for various device classes and types, including legacy devices and custom-made implants. Sistemir also provides training courses and keeps clients updated on regulatory changes and MDCG guidelines. Their approach emphasizes a structured, repeatable methodology with dedicated project teams to ensure efficient and effective support for clients aiming to place medical devices on the European market.
About
**Who they are**
SistemIR provides expert consultancy for CE marking of medical devices, focusing on European regulations, UDI implementation, and Eudamed registration. They assist manufacturers, importers, and other economic operators in navigating complex regulatory requirements.
**Expertise & scope**
* Consultancy for European medical device regulations
* CE marking for medical devices
* ISO 13485 and MDSAP quality systems
* Technical documentation preparation
* UDI implementation and Eudamed registration support
* Training courses
* Assistance with Actor Registration in Eudamed to obtain the Single Registration Number (SRN)
* Support for UDI-DI registration in Eudamed, including manual and bulk upload methods
* Guidance on Eudamed modules including Actor Registration, UDI/Devices, Vigilance, Clinical Investigations, and Certificates & Notifications
* Support for registration of medical devices in the Italian Ministry of Health database
* Assistance with notification obligations for market entry in EU countries
**Reputation / proof points**
* Coverage: EU
SistemIR provides expert consultancy for CE marking of medical devices, focusing on European regulations, UDI implementation, and Eudamed registration. They assist manufacturers, importers, and other economic operators in navigating complex regulatory requirements.
**Expertise & scope**
* Consultancy for European medical device regulations
* CE marking for medical devices
* ISO 13485 and MDSAP quality systems
* Technical documentation preparation
* UDI implementation and Eudamed registration support
* Training courses
* Assistance with Actor Registration in Eudamed to obtain the Single Registration Number (SRN)
* Support for UDI-DI registration in Eudamed, including manual and bulk upload methods
* Guidance on Eudamed modules including Actor Registration, UDI/Devices, Vigilance, Clinical Investigations, and Certificates & Notifications
* Support for registration of medical devices in the Italian Ministry of Health database
* Assistance with notification obligations for market entry in EU countries
**Reputation / proof points**
* Coverage: EU
Additional information
SistemIR specializes in guiding economic operators through the complexities of Eudamed registration. They offer comprehensive support for obtaining the Single Registration Number (SRN) and registering UDI-DI codes, utilizing both manual and bulk upload methods. Their services extend to assisting with various Eudamed modules, including Actor Registration, UDI/Devices, Vigilance, Clinical Investigations, and Certificates & Notifications. They also support the registration of medical devices in the Italian Ministry of Health database and help clients meet notification obligations for market entry across the European Union.
Key Highlights
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Provides expert consultancy for CE marking of medical devices, focusing on European regulations, UDI implementation, and Eudamed registration.
Source
“Sistemir provides expert consultancy for CE marking of medical devices, focusing on European regulations, UDI implementation, and Eudamed registration.”
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Assists manufacturers, importers, and other economic operators in navigating complex regulatory requirements.
Source
“They assist manufacturers, importers, and other economic operators in navigating complex regulatory requirements.”
-
Offers comprehensive support for obtaining the Single Registration Number (SRN) in Eudamed.
Source
“Gestiamo la registrazione in Eudamed degli operatori economici quali fabbricanti, importatori e mandatari al fine di ottenere il Single Registration Number (SRN).”
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Supports the registration of UDI-DI codes in Eudamed using manual and bulk upload methods.
Source
“Registriamo gli UDI-DI di base e gli UDI-DI in Eudamed con metodi di caricamento manuale e massivo.”
Certifications & Trust Signals
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Coverage across the EU for their services.
Source
“Coverage: EU”
Buyer Snapshot
Best for
- Manufacturers seeking Eudamed registration support
- Importers needing assistance with regulatory compliance
- Economic operators navigating EU medical device regulations
How engagement typically works
- Consultancy-based support
- End-to-end registration assistance
- Training and guidance
Typical deliverables
- Obtained Single Registration Number (SRN)
- Registered UDI-DI codes in Eudamed
- Completed Eudamed actor registrations
- Guidance on market entry notifications
Good to know
- Best when requiring expert navigation of Eudamed and EU medical device regulations.
HQ:
Lecco, IT
Languages:
English
Timezones:
Europe/Brussels
Claim status:
Listed
Services & Capabilities
Best EUDAMED Registration| Compare & Get Quotes
Jurisdictions:
EU
Countries:
SE, IT, DK, AT, BE, ES, IE
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
Supports Training Enablement:
Yes
Data Load Support Level:
Done-for-you
Turnaround SLA:
Custom
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
Preparation of organization accounts, assignment of appropriate roles, collection and organization of medical device information, registration of UDI-DI and UDI-DI in Eudamed, registration of medical devices in the Italian Ministry of Health database, and fulfillment of notification obligations for market entry.
Data Load Notes
Data load support level indicates whether uploads are done-for-you, guided, or training-only (seed summary).
Modules Supported
Actor, UDI/Devices, Vigilance, Clinical Investigations, Certificates & Notifications
Supports Actor Registration
true
Supports UDI
true
Supports Vigilance
true
Supports Clinical Investigations
true
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