R-TF-001-006 IFU and label validation 2023_001
Medical device
| Information | |
|---|---|
| Device name | Legit.Health Plus (hereinafter, the device) |
| Model and type | NA |
| Version | 1.0.0.0 |
| Basic UDI-DI | 8437025550LegitCADx6X |
| Certificate number (if available) | MDR 792790 |
| EMDN code(s) | Z12040192 (General medicine diagnosis and monitoring instruments - Medical device software) |
| GMDN code | 65975 |
| Class | Class IIb |
| Classification rule | Rule 11 |
| Novel product (True/False) | FALSE |
| Novel related clinical procedure (True/False) | FALSE |
| SRN | ES-MF-000025345 |
Previous considerations about the nature of the IFU
The stipulations that are specific to the IFU, a part from this record, are contained in the section Minimum IT requirements in the IFU of the procedure GP-001 Control of documents. There, we clarify an issue that is of utmost significance, and that may not be evident; which we now explain also here. But for the reasons you will now understand, the procedure GP-012 Design, Redesign and development and the record R-TF-012-006 Lifecycle plan and report are also key to understanding our IFU.
As explained in GP-001 Control of documents, it's key to understand that we develop and release the IFU exactly as we work in the development and the release of our medical device (and the QMS for that matter).
For further clarification: our IFU is not some PDF that is written in Microsoft Word and then exported. Neither is a Adobe InDesign or Aobe Illustrator file that a designer prepares and exports. It's the furthest thing from that. We develop and deploy our IFU like it was code, because it is code. In other words, we develop and release our IFU following the same process as the medical device; thoroughly explained in our QMS. Our IFU is not a PDF nor a website, our IFU is a code repository managed in Git, just like the device itself, that is accessible also via a URL.
This includes inherent procedures and measures explained in GP-012 Design, Redesign and development and R-TF-012-006 Lifecycle plan and report, such as:
- Managing the content and the versions though Git
- Editing the content using signed commits with GPG Keys
- Using a branch structure with approvals for merging changes
- Automated verification of code correctness and lack of bugs or errors before merge
- Programmatic deployment, directly to the server, after checks have passed
- Secure stage of environmet variables in Git repository
- Redundant backups, both in Git repository and deployment server
- Resiliency of hosting and scrutiny of involved suppliers (as per
GP-010 Purchases and suppliers evaluation) - and many more safeguards explained in
R-TF-012-006 Lifecycle plan and report.
In other words, the IFU is maintained in accordance with the highest security standards, and it enjoys all the benefits of being maintained as code, just like our device; but even more secure, because it does not accept calls nor it outputs data, it simply hosts the content of the IFU which is generated in accordance with the QMS.
Label validation
The label must include the following information and fulfil the following requirements:
| Requirement | Validation | Notes |
|---|---|---|
| The name or trade name of the device. | TRUE | |
| The name or trade name and address of the manufacturer. | TRUE | |
| The details strictly necessary to identify the device and the contents of the packaging. | TRUE | |
| The lot number or the serial number of the device. | TRUE | |
| The UDI code. | TRUE | |
| The special storage and/or handling conditions. | TRUE | |
| Any special operating instructions. | TRUE | |
| Any warnings and/or precautions to take. | TRUE | |
| Manufacture date. | TRUE | |
| If the intended purpose of the device is not obvious to the user, it must be clearly stated. | TRUE | |
| An indication that the device is a medical device. | TRUE |
Due to the nature of our device and according to MDR 2017/745 regulation Annex IV Part C, 6.5.4 part (c), we provide the label information, including the UDI, through the json output of the device, but without the symbols required by the regulation. We include within this information the direct URL to the Instructions for Use where the label can also be consulted with all the symbols required and the device intended purpose, to comply with the MDR 2017/745 GSPR 23.1 (a) and (b) regarding the access and view of both documents by the users.
Evidence
IFU validation
The validation of the electronic IFU was performed to confirm the compliance with, not only the 2017/745 MDR regulation, but also the Commission implementing regulation (EU) 2021/2226 regarding the electronic instructions for use of medical devices.
As such, the IFU must include the following information and fulfil the following requirements:
| Requirement | Validation | Notes |
|---|---|---|
| The name or trade name of the device. | TRUE | |
| The name or trade name and address of the manufacturer. | TRUE | |
| The details strictly necessary to identify the device and the contents of the packaging especially for the users. | TRUE | |
| The special storage and/or handling conditions. | TRUE | |
| Any special operating instructions. | TRUE | |
| Any warnings and/or precautions to take. | TRUE | |
| Device's intended purpose with a clear specification of indications, contra-indications, targeted patients and intended users. | TRUE | |
| The classification of the device according to the applicable standards. | TRUE | |
| Warning for any undesirable side effects. | TRUE | |
| All information needed to verify whether the device can operate correctly and safely, with details of the nature and frequency of the maintenance to ensure safety and performance. | TRUE | |
| Information regarding the risks of reciprocal interference posed by the presence of the device during specific treatment. | TRUE | |
| Any contra-indications or precautions to be taken for the device safety use and performance. | TRUE | |
| Date of issue of the instructions for use. | TRUE | |
| A notice to the user and/or patient that any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent national authority. | TRUE |
Other IFU validation activities performed
As show, the validation of our Instruction for Use has been executed with diligence and has yielded successful results. This validation process was comprehensive and incorporated several critical aspects, underscoring our commitment to delivering a medical device that prioritizes user safety, regulatory compliance, and effective usability.
However, we also validate and check for additional issues, included in this section:
Risk Analysis
The validation of the IFU commenced with a rigorous risk analysis. Our dedicated team of experts, in collaboration with our safety and quality assurance personnel, meticulously assessed potential risks associated with the use of our medical device. This analysis involved the identification, evaluation, and mitigation of risks to ensure that our IFU provides users with clear and effective guidance on mitigating these risks.
More specifically, it also includes the risks evaluated according to the Commission implementing regulation (EU) 2021/2226 regarding the electronic instructions for use of medical devices. To that effect, the IFU must include the following information and fulfil the following requirements:
Editable file here: https://docs.google.com/spreadsheets/d/1O2-RnMmjQkV6lk4ROZhlJvLOP60y_UfWU-uKUleZzNM/edit?usp=drive_link
| ID | Requirement | Evidence of conformity |
|---|---|---|
| Article 4 | Manufacturers of devices referred to in Article 3, paragraphs 1 and 3, that provide instructions for use in electronic form to users instead of in paper form shall undertake a documented risk assessment which shall cover at least the following elements: | |
| 1a | knowledge and experience of the intended users in particular regarding the use of the device and user needs; | Risks 5, 6, 8, 16, 17, 18, 19, 36 |
| 1b | characteristics of the environment in which the device will be used; | Risks 16, 31 |
| 1c | knowledge and experience of the intended user of the hardware and software needed to display the instructions for use in electronic form; | Risks 63; SP-001-001 eIFU managememt |
| 1d | access of the user to the reasonably foreseeable electronic resources needed at the time of use; | Risk 53 |
| 1e | performance of safeguards to ensure that the electronic data and content are protected from tampering; | Risk 55, 64; GP-001 Control of documents |
| 1f | safety and back-up mechanisms in the event of a hardware or software fault, particularly if the instructions for use in electronic form are integrated within the device; | Risk 53 |
| 1g | foreseeable medical emergency situations requiring the provision of information in paper form; | Not applicable, the device is not intended to be used for emegencies |
| 1h | impact caused by the temporary unavailability of the specific website or of the internet in general, or of their access in the healthcare institution as well as the safety measures available to cope with such a situation; | Risk 53 |
| 1i | evaluation of the period within which the instructions for use shall be provided in paper form at the user's request; | The period set for providing the client with IFU in paper format is 7 calendar days (at the latest) of receiving the request. This period is defined in the procedure SP-001-001 eIFU management |
| 1j | assessment of the website's compatibility displaying the electronic instructions for use with different devices which could be used to display those instructions; | Risk 56 |
| 1k | management of different versions of the instructions for use, where applicable in accordance with Article 5(8). | Described in the procedure procedure GP-012 Design, Redesign and Development section Ensuring that customers use the latest version in the IFU there will be a drop-down containing the different versions of the IFU to select each of them and view the specifications of each version. Risk 57 |
| Article 5 | Manufacturers of devices referred to in Article 3, paragraphs 1 and 3, may provide instructions for use to users in electronic form instead of in paper form under the following conditions: | |
| 1 | the risk assessment referred to in Article 4 shall demonstrate that providing instructions for use in electronic form maintains or improves the level of safety obtained by providing the instructions for use in paper form; | R-TF-001-006 IFU and label validation 2023_001 |
| 2 | they shall provide instructions for use in electronic form in all Member States where the product is made available or put into service unless duly justified in the risk assessment referred to in Article 4; | R-TF-001-006 IFU and label validation 2023_001. The IFU are designed as a website and every user with internet connection and the proper url can access to them. |
| 3 | they shall have a system in place to provide the instructions for use in paper form at no additional cost for the user, within the time period set out in the risk assessment referred to in Article 4 and at the latest within 7 calendar days of receiving a request from the user or at the time of delivery of the device if so requested at the time of order; | Process for the managememt of paper IFU request is explained in SP-001-001 eIFU management |
| 4 | they shall provide, on the device or a leaflet, information on foreseeable medical emergency situations and, for devices fitted with a built-in system visually displaying the instructions for use, information on how to start the device; | Due to the nature and intended purpose of our device, the occurrence of medical emergency situations is not possible: the failure of the medical device would not cause immediate harm to the patient as it is always intended for diagnostic and monitoring assistance by healthcare professionals. Additionally, we include the eIFU URL in the output of the device to ensure that users can easily access it once it is integrated. |
| 5 | they shall ensure the proper design and functioning of the instructions for use in electronic form and provide verification and validation evidence to this effect; | R-TF-001-006 IFU and label validation 2023_001 |
| 6 | for medical devices fitted with a built-in system visually displaying the instructions for use, they shall ensure that displaying the instructions for use does not impede the safe use of the device, in particular, life-monitoring or life- supporting functions; | NA |
| 7 | they shall provide, in their catalogue or other appropriate device information support, information on software and hardware requirements needed to display the instructions for use; | Risk 56, SP-001-001 eIFU management |
| 8 | they shall have a system in place to clearly indicate when the instructions for use have been revised and to inform each user of the device thereof if the revision was necessary for safety reasons; | The IFU contains on its main page a table reporting the version history and they will include this information when required according to our procedure GP-001 Control of documents |
| 9 | for devices with a defined expiry date, except implantable devices, they shall keep the instructions for use available for users in electronic form for 10 years after the last device has been placed on the market and at least 2 years after the end of the expiry date of the last produced device; | The device has not a defined expiry date |
| 10 | for devices without a defined expiry date and implantable devices, they shall keep the instructions for use available for the users in electronic form for 15 years after the last device has been placed on the market; | Defined at the GP-001 Control of documents |
| 11 | the instructions for use shall be available on their website in an official language of the Union determined by the Member State in which the device is made available to the user or patient; | The translation process for IFU is explained in GP-022 Document translation |
| 12 | effective systems and procedures shall be in place to ensure that device users having downloaded instructions for use from the website can be informed in case of updates or corrective actions with regards to those instructions for use; the most effective system being users not downloading the IFU, but always consulting it in the URL. As such, no download link is provided and the IFU shall include a notice saying that downloading is not advised, and explaining why. | There is an explanatory note at the IFU recommending to use the cloud version of the IFU. When a new version of the device is released together with the new version of the IFU we follow the GP-012 Design, Redesign and development procedure section Ensuring that customers use the latest version |
| 13 | all issued historical electronic versions of the instructions for use shall be available on the website. | Explained in section "IFU and device versioning" |
| Article 6 | ||
| 1 | Manufacturers shall clearly indicate on the label that the instructions for use of the device are supplied in electronic form instead of in paper form. | R-TF-001-008 Legit.Health Plus label 2023_001 |
| 2 | Manufacturers shall provide information on how to access the instructions for use in electronic form. | We inform our customers that the IFU are place at our website, and we also provide them with the url when requested. The eIFU are also available as output of the device. The different options for accessing IFU are also detailed in the procedure SP-001-001 where an explanation on how this information is provided to customers is available. |
| 3 | The information on how to access the instructions for use in electronic form shall also contain the following: | |
| 3a | any information needed to view the instructions for use; | We inform our customers that the IFU are place at our website, and we also provide them with the url when requested. |
| 3b | the Basic UDI-DI and/or the UDI-DI of the device, as respectively referred to in Article 27(6) and Article 27(1), point (a) (i), of Regulation (EU) 2017/745, and any additional information allowing the identification of the device, including its name and if applicable the model; | The IFU contains the device labelling with the UDI. |
| 3c | relevant manufacturer contact details e.g. manufacturer's name, address, email address or other means of online communication and website; | The IFU contains the manufacturer information |
| 3d | where and how instructions for use in paper form can be requested and within which time they shall be obtained at no additional cost in conformity with Article 5, point (3). | Process for paper IFU request and management is explained in SP-001-001 eIFU management |
| 4 | Where, for devices and accessories referred to in Article 3(1), point (a), a part of the instructions for use is intended to be provided to the patient, that part shall not be provided in electronic form. | The device is not intended to be used by patients. |
| 5 | The instructions for use in electronic form shall be available entirely as text, which may contain symbols and graphics, with at least the same information as the instructions for use in paper form. Video or audio files may be provided in addition to the text. | Legit.Health Plus IFU |
| Article 7 | ||
| 1 | Where manufacturers provide the instructions for use in electronic form on an electronic storage medium together with the device, or where the device itself is fitted with a built-in system visually displaying the instructions for use, the instructions for use in electronic form shall also be made accessible to the users through a website. | We publish the device IFU in our website https://legit.health/ |
| 2 | Any website containing instructions for use of a device which are provided in electronic form instead of in paper form shall comply with the following requirements: | |
| 2a | the instructions for use shall be provided in a commonly used format that can be read with freely available software; | The IFU are designed as a website and every user with internet connection and the proper url can access to them. |
| 2b | it shall be protected against unauthorised access and tampering of content in accordance with Article 4(1), point (e); | Risk 55; GP-001 Control of documents; SP-012-002 Cybersecurity and Transparency Requirements. This requirement is alos implemented by designing and by managing the IFU following the same procedure we follow with the device, and by applying the same security measures |
| 2c | it shall be provided in such a way that the server downtime and display errors are reduced as far as possible; | Risk 53 |
| 2d | it shall fulfil the requirements of Regulation (EU) 2016/679 (GDPR) by adding link to the Privacy Policy, Cookies Policy and Legal notice, and by ensuring that no personal identifiable data is collected, except in the support form that includes the relevant privacy notice; | The electronic IFU complies with the requirements of Regulation (EU) 2016/679. |
| 2e | the internet address as displayed in accordance with Article 6(2) shall be stable and directly accessible during the periods set out in Article 5, points (9) and (10); | Defined at the GP-001 Control of documents |
| 2f | all previous versions of the instructions for use issued in electronic form as referred to in Article 5, point (13), and their date of publication shall be available on the website. | Explained in section "IFU and device versioning" |
This analysis demonstrate that providing instructions for use in electronic form improves the level of safety obtained by providing the instructions for use in paper form.
IFU and device versioning
For many reasons, including safety and performance, it is best to avoid old versions of the IFU to be used by users. Instead, it's best to ensure that users allways use the latest version of the IFU.
In our case, due to the nature of the device, it is possible to achieve this because there is no way of using the device without internet access; and also because the output of the device outputs, every time, a link to the IFU. As such, the risk of not having the IFU available whilst using the device is zero.
However, it is very useful to allow users to see the documentation for the previous versions of the device. As explained in GP-012, we ensure that customers use the latest version. However, since this process is not immediate, they should be able to see the information for the previous version. Also, they may have mere curiosity about how previous versions looked, and we want to satisfy that curiosity.
Combining all these considerations, we have programmed the IFU to allow users to see the API endpoints for previous versions of the device, directly from the latest release of the IFU. This is different to keeping the old version of the IFU: that the updated version of the IFU includes information relevant to the previous versions of the device.
To achieve this, in the sections that show the output of the device, users see a dropdown wherein they can select the version, and the content of the section will update with that information.
Regulatory Compliance
We are proud to confirm that our IFU has been scrutinized for compliance with all relevant regulatory requirements, including those mandated by the EU Medical Device Regulation (MDR). Our team ensured that the content of the IFU aligns with the latest regulatory standards and guidelines, including the electronic IFU regulation, reflecting our unwavering commitment to adhering to the highest industry standards and maintaining the safety and effectiveness of our medical device.
Usability Testing
The validation process culminated with extensive usability testing of the IFU, as it is recorded at the R-TF-012-008 Software usability report_2023_001. This critical phase involved engaging a diverse group of users, including healthcare practitioners, medical professionals, and relevant stakeholders. The usability testing was conducted under real-world conditions to assess the clarity, comprehensibility, and effectiveness of the instructions provided in the IFU. The overwhelmingly positive results affirm that our IFU successfully facilitates the safe and effective use of our medical device.
Post-Market Clinical Follow-up (PMCF) Activities
In parallel, we conducted rigorous PMCF activities to gather real-world data regarding the performance and safety of our device in the clinical environment. These ongoing activities have provided valuable insights into device use, user feedback, and any unanticipated issues, allowing us to make informed adjustments and refinements to the IFU.
Clinical studies
Our validation process was further enriched by comprehensive clinical studies that involved close collaboration with healthcare professionals and clinical experts. These studies offered invaluable data on the device's performance, its impact on clinical decision-making, and its usability in real clinical scenarios.
Leveraging results of the previous generation of the device
In addition to the above activities, we also based our results on the previous generation of the device. This approach allowed us to harness the knowledge and experience gained from the prior version, facilitating a more informed and improved IFU for the current device generation.
In conclusion, our validated IFU stands as a testament to our commitment to delivering a medical device that prioritizes user safety, regulatory compliance, and effective usability. We have taken multifaceted approaches, incorporating risk analysis, regulatory compliance, usability testing, PMCF activities, and clinical studies, along with the valuable insights gained from our previous device generation.
Our dedication to quality, safety, and user satisfaction remains unwavering. We are confident that our validated IFU reflects these principles, ensuring that our medical device empowers healthcare professionals to deliver the highest standards of care.
Record signature meaning
- Author: JD-004 Giulia Foglia
- Review: JD-003 Taig Mac Carthy
- Approver: JD-005 Alfonso Medela