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**
* Assistance with CE marking for medical devices.
* Guidance on European regulations for medical devices.
* Support for ISO 13485 and MDSAP quality systems.
* Technical documentation preparation.
* UDI implementation and Eudamed registration.
* Training courses on relevant regulations.
* Consultancy on Eudamed actor registration, including obtaining the Single Registration Number (SRN).
* Support for UDI-DI registration in Eudamed, utilizing both manual and bulk upload methods.
* Registration of medical devices in the Italian Ministry of Health database.
* Guidance on meeting notification obligations for market entry within the European Union.
* Expertise in navigating the Eudamed database, which supports the implementation of European Regulations 2017/745 (MDR) and 2017/746 (IVDR).
* Assistance with the registration of economic operators (manufacturers, authorized representatives, importers) and devices within Eudamed.
* Support for obtaining and implementing Unique Device Identification (UDI) codes, including validation of the printing process.
**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**
* Assistance with CE marking for medical devices.
* Guidance on European regulations for medical devices.
* Support for ISO 13485 and MDSAP quality systems.
* Technical documentation preparation.
* UDI implementation and Eudamed registration.
* Training courses on relevant regulations.
* Consultancy on Eudamed actor registration, including obtaining the Single Registration Number (SRN).
* Support for UDI-DI registration in Eudamed, utilizing both manual and bulk upload methods.
* Registration of medical devices in the Italian Ministry of Health database.
* Guidance on meeting notification obligations for market entry within the European Union.
* Expertise in navigating the Eudamed database, which supports the implementation of European Regulations 2017/745 (MDR) and 2017/746 (IVDR).
* Assistance with the registration of economic operators (manufacturers, authorized representatives, importers) and devices within Eudamed.
* Support for obtaining and implementing Unique Device Identification (UDI) codes, including validation of the printing process.
**Reputation / proof points**
* Coverage: EU
Additional information
SistemIR offers comprehensive support for Eudamed registration, covering various actor roles such as manufacturers, importers, and authorized representatives. They facilitate the process of obtaining the Single Registration Number (SRN) and assist in preparing the necessary documentation and organizational accounts. Their services extend to the registration of UDI-DI (both basic and advanced) within Eudamed, employing efficient manual and bulk upload methods. For manufacturers, they also manage the registration of medical devices in the Italian Ministry of Health database, ensuring compliance with national and EU market access requirements.
Key Highlights
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SistemIR provides expert consultancy for CE marking of medical devices.
Source
“Consulenza regolamento europeo dispositivi medici Marcatura CE dispositivi medici”
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They offer support for UDI implementation and Eudamed registration.
Source
“UDI e registrazione Eudamed”
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Assistance is provided for Eudamed actor registration, including obtaining the Single Registration Number (SRN).
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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They support the registration of medical devices in the Italian Ministry of Health database.
Source
“Ci occupiamo della registrazione dei dispositivi medici nella banca dati del Ministero della Salute italiano, anche con metodi di caricamento massivo.”
Certifications & Trust Signals
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SistemIR is an EU-based provider.
Source
“Copyright © 2026 Sistemir EU S.r.l. Tutti i diritti riservati.”
Buyer Snapshot
Best for
- Manufacturers seeking CE marking and EU regulatory compliance.
- Importers and Authorized Representatives navigating Eudamed requirements.
- Companies needing assistance with UDI implementation and registration.
How engagement typically works
- Consultancy and direct assistance.
- Process management and documentation support.
- Training and guidance.
Typical deliverables
- CE marking documentation.
- Eudamed Actor registration (SRN).
- UDI registration and implementation.
- Medical device registration in national databases.
- Compliance guidance and training.
Good to know
- Best when requiring specialized knowledge of EU medical device regulations (MDR/IVDR) and Eudamed.
HQ:
Lecco, IT
Languages:
English
Timezones:
Europe/Brussels
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
The process involves creating an EU Login Account, registering as an Actor, obtaining an SRN, adding users, and potentially registering devices and UDI-DI.
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
