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QMS
  • Welcome to your QMS
  • Quality Manual
  • Procedures
    • GP-001 Control of documents
      • Annex 1 Responsibility matrix
      • Deprecated
      • Templates
      • Specific procedures
        • SP-001-001 eIFU management
    • GP-002 Quality planning
    • GP-003 Audits
    • GP-004 Vigilance system
    • GP-005 Human Resources and Training
    • GP-006 Non-conformity, Corrective and Preventive actions
    • GP-007 Post-market surveillance
    • GP-008 Product requirements
    • GP-009 Sales
    • GP-010 Purchases and suppliers evaluation
    • GP-011 Provision of service
    • GP-012 Design, Redesign and Development
    • GP-013 Risk management
    • GP-014 Feedback and complaints
    • GP-015 Clinical evaluation
    • GP-016 Traceability and identification
    • GP-017 Technical assistance service
    • GP-018 Infrastructure and facilities
    • GP-019 Software validation plan
    • GP-020 QMS Data analysis
    • GP-021 Communications
    • GP-022 Document translation
    • GP-023 Change control management
    • GP-024 Cybersecurity
    • GP-025 Corporate Governance
    • GP-050 Data Protection
    • GP-051 Security violations
    • GP-052 Data Privacy Impact Assessment (DPIA)
    • GP-100 Business Continuity (BCP) and Disaster Recovery plans (DRP)
    • GP-101 Information security
  • Records
  • TF_Legit.Health_Plus
  • Licenses and accreditations
  • External documentation
  • Procedures
  • Records
  • Procedures
  • GP-001 Control of documents
  • Specific procedures
  • SP-001-001 eIFU management

SP-001-001 eIFU management

Purpose​

To define the method to manage the electronic Instructions For Use (eIFU) and their availability to users.

Scope​

The eIFU of the device and their translations.

Responsibilities​

JD-001​

To provide the organisation with a set of appropriate resources to guarantee the compliance of eIFU with the applicable regulatory requirements and to guarantee customer's needs.

JD-004​

To ensure availability of eIFU to users and to ensure the process for paper IFU is correctly followed.

JD-005​

To ensure availability of eIFU to users and to ensure customers received the requested paper IFU according to the timeline defined in this procedure.

JD-002, JD-008, JD-019​

To handle clients request related to paper IFU and to follow the process established in this procedure.

Inputs​

  • Regulation (EU) 2021/2226 (electronic instructions for use of medical devices).

Outputs​

  • eIFU compliant with Regulation.
  • paper IFU available to clients.

Development​

eIFU availability to users​

The IFU of our device are provided in electronic format due to the nature of the device (more information about IFU design, validation and IT security measures are detailed in GP-001 - Documents and records control).

There are 3 options for users to get access to the IFU:

  • Legit.health website: the users can access our website and consult the eIFU.
  • URL: the IFU is accessible through a dedicated and secure URL.
  • Output of the device: the IFU is integrated into the output of our medical device's API, allowing users to access it as a key-value pair.

The only requirement for accessing the eIFU is having internet connection. The users can access the IFU via any web browsers with any operations system.

This information is provided to the clients during the sales process as part of the device information shared with the customers.

Paper IFU request​

This section explains how we fulfil a customer's request related to paper IFU.

The IFU of our device are available only in electronic format, es explained in the section above. In case a customer would like to consult the IFU in a paper format, we establish a process to fulfil the customer's need.

Customers can request paper IFU by using one of the following options:

  • eIFU section called Request paper IFU: the client will fill in a form to request the paper IFU, Legit.Health will receive the notification and will manage the request.
  • Direct emails to sales team by using the following email address: sales@Legit.health
  • Website section called Got questions? Reach out where the customers can submit their request.

The last two options are recommended when users encounter issues to access the electronic IFU.

Information on how to request paper IFU is also provided as an output of the device. More precisely, the device will return the following message (among others): Instructions for use in paper form can be requested through a form in the electronic instructions for use, and will be shipped in 7 days at no additional cost in conformity with Article 5 of regulation 2021/2226.

Once the request is received, one of the sales team members will manage the request, this means the following:

  • The assigned sales person will ask any missing information to the customer in order to fulfil the request (e.g. shipping address of the client).
  • The assigned sales person will take care of printing the IFU.
  • The assigned sales person will take care of the shipping process and he/she will follow up wih the client to ensure the paper IFU has been correctly shipped.

The paper IFU will be provided to the customer at the latest within 7 calendar days of receiving the request (according to the outcomes of the risk analysis) and paper IFU will be provided at no additional cost for the client.

Associated documents​

  • GP-001 - Documents and records control

Signature meaning

The signatures for the approval process of this document can be found in the verified commits at the repository for the QMS. As a reference, the team members who are expected to participate in this document and their roles in the approval process, as defined in Annex I Responsibility Matrix of the GP-001, are:

  • Author: JD-003, JD-004
  • Reviewer: JD-005
  • Approver: JD-001
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Specific procedures
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GP-002 Quality planning
  • Purpose
  • Scope
  • Responsibilities
    • JD-001
    • JD-004
    • JD-005
    • JD-002, JD-008, JD-019
  • Inputs
  • Outputs
  • Development
    • eIFU availability to users
    • Paper IFU request
  • Associated documents
All the information contained in this QMS is confidential. The recipient agrees not to transmit or reproduce the information, neither by himself nor by third parties, through whichever means, without obtaining the prior written permission of Legit.Health (AI LABS GROUP S.L.)