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 (MDR/IVDR).
* CE marking assistance for medical devices.
* ISO 13485 and MDSAP quality system support.
* Technical documentation preparation.
* UDI implementation and Eudamed registration services.
* Training courses.
* Support for Actor registration in Eudamed, including obtaining the Single Registration Number (SRN).
* Assistance with UDI-DI registration in Eudamed, using manual and bulk upload methods.
* Registration of medical devices in the Italian Ministry of Health database.
* Guidance on notification obligations for market placement in EU countries.
* Support for healthcare institutions and operators regarding UDI registration for implantable devices.
**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 (MDR/IVDR).
* CE marking assistance for medical devices.
* ISO 13485 and MDSAP quality system support.
* Technical documentation preparation.
* UDI implementation and Eudamed registration services.
* Training courses.
* Support for Actor registration in Eudamed, including obtaining the Single Registration Number (SRN).
* Assistance with UDI-DI registration in Eudamed, using manual and bulk upload methods.
* Registration of medical devices in the Italian Ministry of Health database.
* Guidance on notification obligations for market placement in EU countries.
* Support for healthcare institutions and operators regarding UDI registration for implantable devices.
**Reputation / proof points**
* Coverage: EU
Additional information
SistemIR assists economic operators in understanding and fulfilling Eudamed registration obligations. This includes preparing the necessary documentation and ensuring correct data submission for devices and actors. They also support healthcare institutions in managing UDI data for implantable devices, a requirement that has been in effect since January 15, 2024. Their services aim to streamline the complex process of regulatory compliance within the European Union.
Key Highlights
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Provides expert consultancy for CE marking of medical devices.
Source
“Consulenza regolamento europeo dispositivi medici Marcatura CE dispositivi medici”
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Assists with UDI implementation and Eudamed registration for economic operators.
Source
“Ci occupiamo dell’ottenimento del codice UDI interfacciandoci con gli organismi di rilascio e supportiamo il cliente nell’implementazione dei codici ottenuti e nella validazione del processo di stampa. 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 healthcare institutions with UDI registration for implantable devices.
Source
“Le istituzioni sanitarie e gli operatori sanitari – qualora questi non esercitino la propria attività professionale nel contesto di una istituzione sanitaria – devono registrare e conservare l’identificativo unico del dispositivo (UDI) dei dispositivi medici impiantabili che hanno fornito (implantato) o ricevuto.”
Certifications & Trust Signals
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Focuses on European regulations, including MDR and IVDR.
Source
“Consulenza regolamento europeo dispositivi medici”
Buyer Snapshot
Best for
- Manufacturers seeking CE marking and Eudamed compliance.
- Importers and other economic operators navigating EU medical device regulations.
- Healthcare institutions needing UDI registration support.
How engagement typically works
- Consultancy and direct support for regulatory processes.
- Training and guidance on compliance requirements.
- Assistance with data preparation and submission.
Typical deliverables
- CE marking documentation.
- Eudamed Actor registration (SRN).
- UDI-DI registration in Eudamed.
- Italian Ministry of Health database registration.
- Market placement notification support.
Good to know
- Best when engaging early in the product lifecycle for CE marking and UDI implementation.
HQ:
Lecco, IT
Languages:
English
Timezones:
Europe/Brussels
Claim status:
Listed
Services & Capabilities
Find 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
SistemIR prepares organization accounts, assigns appropriate roles for registration, and provides tools to gather and organize medical device information for Eudamed registration. They handle manual and bulk upload methods for UDI-DI registration.
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
Supports Actor Registration
Yes
Supports UDI
Yes
Supports Vigilance
No
Supports Clinical Investigations
No
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