FAQ
Answers to the most common questions about Scan & Care and the management of digital IFUs.
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Does Scan & Care guarantee MDR compliance of IFUs?
No.
Scan & Care is an IT support platform designed to help manufacturers manage IFUs digitally.
The responsibility for regulatory compliance always remains entirely with the medical device manufacturer.
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What is the role of Scan & Care compared to the manufacturer?
Scan & Care provides:
- IT infrastructure;
- IFU hosting;
- distribution via QR code;
- versioning and traceability.
Scan & Care does not validate, approve, or certify regulatory content and does not make regulatory decisions.
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Can Scan & Care be considered an outsourced process for ISO 13485?
Yes, if the manufacturer decides so.
By default Scan & Care operates as an IT support tool.
The manufacturer can formally include it among the outsourced processes of its QMS and define the applicable controls.
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Who decides when an IFU is valid and publishable?
The decision always belongs to the manufacturer through its authorized RA/QA users.
Scan & Care simply records and makes all actions traceable.
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How are IFU versions managed?
Each IFU is managed with:
- structured versioning;
- association to product and language;
- preservation of published versions;
- a searchable history.
You can always demonstrate which version was valid in a specific period.
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Can a published IFU be deleted?
No.
Published IFU versions cannot be deleted from the system.
This guarantees document history preservation and the ability to reconstruct what was provided to users.
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What happens if an IFU contains an error or must be updated urgently?
The manufacturer can:
- immediately deactivate the incorrect version;
- publish a new version;
- keep the history of previous versions.
All actions are tracked via the audit log.
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Does the QR code always point to the latest IFU version?
The QR code gives access to the version associated with the device.
When updates occur, the platform allows the user to:
- see the current version;
- review the history of previous versions.
This behaviour guarantees transparency and traceability.
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How is the language of the IFUs managed?
IFUs are uploaded by the manufacturer for each language.
The platform:
- preselects the language based on the user’s browser;
- always lets the user manually switch to another available language.
Scan & Care does not perform automatic translations.
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Is Scan & Care compliant with the eIFU Regulation (EU) 2021/2226?
Scan & Care is designed to support manufacturers in managing eIFUs in line with Regulation (EU) 2021/2226.
The responsibility for correctly applying the regulation remains with the manufacturer.
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Can a paper IFU be requested?
Yes.
The platform lets the user request a paper IFU.
The request is forwarded to the manufacturer, who fulfils it under their own responsibility. All requests are tracked.
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How is the security of published IFUs guaranteed?
Security is ensured through multiple measures:
- public access is read-only;
- content cannot be modified from the public area;
- access happens via signed and controlled URLs;
- every access is logged.
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Are user actions tracked?
Yes.
Scan & Care features a structured, append-only audit log that records:
- who performed the action;
- which action was executed;
- when it happened;
- which document was involved.
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Does Scan & Care replace the manufacturer’s quality system?
No.
Scan & Care does not replace the manufacturer’s QMS and does not change the MDR obligations.
It is a tool that supports the manufacturer’s processes while leaving the responsibility perimeter unchanged.
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Can this documentation be used during audits?
Yes.
Scan & Care provides:
- validation documentation;
- a regulatory compliance matrix;
- technical evidence and traceability.
These artefacts can be used as supporting evidence during MDR and ISO 13485 audits.
