GP-021 Communications

Purpose

The purpose of this procedure is to ensure effective communication of information related to the medical devices, including safety, clinical performance, post-market surveillance (PMS) findings, and regulatory requirements. This ensures that all stakeholders (internal teams, regulatory authorities, notified bodies, intended users) receive timely and accurate information.

Scope

This procedure covers all communication related to the medical devices (in all stages of the device lifecycle), including:

• Internal communication between departments
• External communication with regulatory bodies (e.g. Competent Authorities, Notified Bodies, FDA)
• External communication with intended users and customers
• Advertisement, social networks, web contents

References

This procedure has been developed following:

• Spanish Royal Decree 1907/1996 regarding advertising and commercial promotion of products, activities or services health purpose
• Spanish Royal Decree 192/2023, regulating the medical devices
• European 2017/745 Medical Devices regulation
• ISO 13485:2016

Responsibilities

JD-001

Responsible for ensuring that adequate resources and channels are available to support effective communication.

JD-004

Responsible for overseeing all communication processes, ensuring compliance with regulatory requirements, and ensuring that all communication records are maintained.

JD-003

Responsible for suggesting and approving changes related to the website of the company.

JD-005

Responsible for managing external communications with regulatory authorities, notified bodies, and vigilance reporting as required by MDR. Responsible for the control of the communication and advertising of the company in relation to the product.

Inputs

• Company information
• Device information (including specifications and features)
• Economic and clinical operators' inquiries/feedback

Outputs

Company communication (internal and external), this includes:

• Communication between departments
• Communication to final customers/intended users
• Social networks
• Webpage
• Communication with distributors
• Fairs and congresses
• Professional events and research environments

Development

Internal communication

Communication between departments is handled by a selected tool (Slack) and by organising periodic meetings.

Slack allows the company members to exchange information, inquiries, news in real-time through instant messaging. This helps facilitating quick and efficient communication, and reducing the need for email or in-person meetings.

Slack also allows us to organize conversations into channels based on projects, teams, or departments, ensuring proper and focused communication between stakeholders.

The other method established to ensure proper internal communication is holding periodic meetings, as detailed in the table below:

Meeting name	Frequency	Lead	Attendees	Objective
Medical data science daily	3 days per week	JD-005	Medical data science team (people involved in the development of the medical device and in clinical validation)	Update team members about the status of assigned tasks and share doubts
Product development weekly	Once a week	JD-003	All design and development team members including regulatory and quality member(s) and project manager	Update product development team members about tasks to work on and any helps needed
Medical data science biweekly	Once every two weeks	JD-005	The whole company	Share information about medical device and new developments with the entire team
Quality biweekly	Once every two weeks	JD-004	The whole company	Share regulatory and quality updates with the entire team
HR weekly	Once a week	JD-006	JD-006, JD-001and any other head of department required	Follow up on human resources matters
Sales daily meeting	Once a day	JD-002	Sales department	Update team members about main goals and help needed
Sales end-of-week meeting	Once a week	JD-002	The whole company	Share sales information and help needed with the entire team

External communication

Communication with Regulatory Authorities and Notified Bodies

The communication with Regulatory Authorities and Notified Bodies usually happens in case of a reportable incident and in case of a change in the device (or in the QMS) that requires notification.

The communication process for vigilance reporting is described in the procedure GP-004 Vigilance system where responsibilities, timelines and steps are detailed.

The communication process for notification of the so called significant changes in design and/or in the QMS is explained in the procedure GP-023 Change control management.

Communication with customers

Customer feedback and complaints

Feedback from customers, including any complaints regarding device performance, safety, or usability, is handled according to the procedure GP-014 Feedback and Complaints. This procedure ensures that:

• All feedback is tracked and analysed in a timely manner.
• Complaints are investigated and addressed according to the established timelines and processes outlined in the procedure.
• Corrective actions, if required, are communicated to customers based on the results of the investigation of the issue. Customers will be promptly notified of safety risks associated with the current version of the device; required corrective actions, such as software patches, updates, or product recalls; clear instructions for mitigating the risks associated with the use of the device.
• The results of feedback analysis are used to improve device performance and risk mitigation strategies.

Notification of new software versions

Customers will be notified of any updates or new versions of the device. This notification includes:

• Details of the changes introduced in the new version, including updates to performance, features, or safety measures.
• Updated instructions for use (IFU) or supplementary documentation, if applicable.
• Recommendations for actions that the customer should take to integrate the new version or ensure continued safe use of the device.

Communication of device's information

The device's information (including information to identify the device, the manufacturer, information about safety and performance, information about the use of the device) is provided in the Instruction for Use (IFU) of the medical device.

The IFU are developed according to the applicable requirements set out in MDR 2017/745 (Annex I, Chapter III) and in Regulation (EU) 2021/2226 about electronic IFU (eIFU).

Up-to-date IFU of the medical device are publicly available in our website and they contain all the necessary information for the safe use of the device (including intended users) and provide performance information based on clinical evidence.

Additionally, in the IFU is clearly indicated which sections apply to the primary intended users and which ones are dedicated to the IT professionals for the correct integration of the device into the healthcare organisation's system.

Advertisement

It is necessary for those involved in communication and marketing to faithfully and truthfully state the regulatory-approved information in the advertising material.

The principles and limits in communications are established in the Article 7 of MDR 2017/745 and they state that in the label, instructions for use, commercialization, putting into service and advertising of devices, it is prohibited to use texts, names, trademarks, pictures and figures or other signs that may mislead the user or the patient regarding the device's intended purpose, safety and performance.

Only when the device has receieved regulatory approval (e.g. CE marking in Europe) all communication can be initiated and must:

• Be certain, concrete and true in relation to the features and specifications documented in the technical documentation of the product. Nothing that is not validated and evidenced by the information contained in the technical documentation can be mentioned.
• Be lawful communications.
• Be controlled and authorised by the authorities (AEMPS).
• Be clear and obvious that it is publicity and that the device is considered a medical device.
• Include a mention to the conformity certificates of the product in application of the applicable legal requirements.
• Include the contraindications and possible side effects of the product.
• Include the CPSP code (Control Previo Sanitario de Producto sanitario), issued by the control authorities and only when there is reference to a medical device.

CPSP code

Regarding Royal Decree 1591/2009 regulation of medical devices, article 38, after due consideration, we deem that it does not apply for the following reasons: firstly, because we do not advertise by paying for advertising in generalist media outlets, and secondly, because all our communication efforts are specifically directed to healthcare providers. Furthermore, we actively make an effort not to target patients, for the main reason that it would be a waste of money because it is impossible for a patient to purchase our device or even to play a role in the decision.

• Contain, and not deform, the approved contents.

The communication can contain:

• Specificity or accuracy of the device, if it is provided from testable and real data, it can be from pre-clinical or clinical data or studies, from post-market surveillance.
• General data from patients' quality of life improvement if it is provided from testable or real data.

The communication cannot contain:

• Commitments or promises of healing.
• Promises of specificity or accuracy for a particular device or patient, or as general rule for all the patients.
• As an advertising argument, the fact of having the certifications and/or licenses required for medical devices.
• No gifts, prizes or contests may be given for the promotion of medical devices.
• Mentions to any health authority not involved in the regulatory process.
• Direct recommendations of experts with a special notoriety for sales.
• Deceitful, disloyal, aggressive or subliminal messages.
• Until the end of the CE marking process, the name of the product cannot be cited and its image (including packaging) won't be displayed. It must be advised that it is in the development and certification phase.

Website

The JD-005 is the responsible for the website content, especially for the most technical or scientific content. When a new change must be performed to the website it will be managed following the GP-023 Change control management. JD-005 and JD-003 will review the information to be modified and the proposed changes before releasing the changes.

Distributors, partners or professionals

It is possible to show the device image, the commercial name, the results of clinical trials, the results of technical tests and other information, with technical, research and development purposes, only in specific environments such as:

• Technical meetings
• Partnering meetings
• Scientific meetings
• Shows, trades or events for:
  • Scientists
  • Clinicians
  • Investors
  • Partners

Fairs and congresses

During fairs and congresses, the device's information and functionality can be shared, but only CE-marked devices can be advertised for sale or use.

The device's claims shall adhere to the guidelines described above and off-label promotion or misleading information are prohibited.

Any presentation of non-CE-marked devices must include a clear disclaimer indicating their investigational status.

Professional events and research environments

The device's information and functionality can be shared, but only CE-marked devices can be advertised for sale or use.

The device's claims shall adhere to the guidelines described above and off-label promotion or misleading information are prohibited.

Any presentation of non-CE-marked devices must include a clear disclaimer indicating their investigational status.

Other environments as social networks

The content for social networks is developed by JD-011 (with the support of any other team members depending on the topic). The approval of the content will be then approved by JD-005.

Associated documents

• GP-004 Vigilance system
• GP-014 Feedback and complaints
• GP-023 Change control management

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: Team members involved
• Reviewer: JD-011
• Approver: JD-001