What is an Electronic Instructions for Use (eIFU)?

How Does It Differ from Traditional Paper-Based IFUs?

eIFU refers to the digital format of IFU documents that provide essential information on the safe and effective use of medical devices. Unlike traditional paper-based IFUs, eIFU is accessible online or via digital platforms, offering real-time updates and enhanced user experience. This transition to digital labeling aligns with the industry’s move toward automation and regulatory digitalization.

Regulatory Requirements for eIFU

Overview of EU MDR, FDA, and Global Regulations on Electronic Labeling

Regulatory authorities worldwide have recognized the benefits of electronic labeling and have set guidelines to govern its implementation:

• EU MDR (Medical Device Regulation) mandates strict compliance with eIFU accessibility and security measures, ensuring users can access up-to-date information without compromising safety.
• FDA (U.S. Food and Drug Administration) allows electronic labeling under specific conditions, particularly for professional-use medical devices, to ensure reliability and compliance.
• Other Global Regulations include varying policies on electronic labeling, often requiring secure access, multilingual support, and data integrity.

Compliance Challenges and How eIFU Solutions Help Overcome Them

• Frequent Updates: Keeping paper IFUs compliant with new regulations can be time-consuming and costly. eIFU enables real-time updates.
• Global Accessibility: Ensuring multilingual support and digital access to IFUs can be complex. eIFU solutions provide a centralized platform for easy distribution.
• Data Security: Regulatory bodies require secure access to prevent unauthorized modifications, which eIFU platforms can ensure with encryption and access controls.

Benefits of Implementing eIFU

Improved Accessibility and Real-Time Updates

eIFU allows users, including healthcare professionals and patients, to access the latest device instructions instantly via online platforms. This eliminates the risk of outdated information and ensures compliance with evolving regulations.

Cost Savings by Reducing Printing and Distribution Expenses

By transitioning to digital IFUs, manufacturers can significantly cut down on printing, storage, and distribution costs while contributing to environmental sustainability by reducing paper waste.

Enhanced User Experience for Healthcare Professionals and Patients

With easy search functionality, interactive features, and multilingual support, eIFU enhances the overall user experience, ensuring that critical medical device information is always within reach.

How Visu-eIFU Simplifies Electronic Labeling

Key Features of Visu-eIFU by DDi

Visu-eIFU is a cutting-edge solution designed to help medical device manufacturers meet regulatory requirements efficiently. Key features include:

• Secure Digital Access: Ensuring compliance with global regulations while safeguarding data integrity.
• Multilingual Support: Catering to global markets by providing IFUs in multiple languages.
• Automated Updates: Real-time information updates without the need for reprinting and redistributing physical IFUs.

Case Studies or Examples of How Companies Have Benefited from Using Visu-eIFU

Several medical device companies have successfully transitioned to eIFU with Visu-eIFU, experiencing improved compliance, cost savings, and enhanced customer satisfaction. Case studies highlight:

• A leading medical device manufacturer reduced labeling costs by 40% after adopting Visu-eIFU.
• A global healthcare provider improved regulatory compliance by automating updates across multiple regions.

Future of Digital Labeling in the Medical Device Industry

Emerging Trends in Regulatory Digitalization

As technology continues to evolve, regulatory bodies are moving towards stricter compliance requirements for digital labeling. The adoption of eIFU is expected to grow as part of the broader digital transformation in the healthcare sector.

How AI and Automation Are Shaping the Future of eIFU

AI-powered eIFU solutions are paving the way for more intelligent and automated document management. From predictive updates to enhanced data analytics, AI will play a critical role in the future of digital labeling.

Conclusion

The shift to electronic IFU is no longer optional but a necessity for medical device companies aiming to enhance compliance and efficiency. Visu-eIFU by DDi provides a seamless solution for transitioning from traditional IFUs to digital formats, ensuring cost savings, real-time updates, and regulatory adherence.

Medical device manufacturers looking to stay ahead in regulatory compliance and operational efficiency should consider integrating eIFU solutions like Visu-eIFU into their labeling strategies. The future of medical device labeling is digital embracing it now will ensure long-term success and compliance.

Medical writing is an important part of the healthcare industry and as AI technology progresses, its applications in medical writing are becoming more common.

AI is revolutionising several industries, including Life sciences. By automating and supplementing numerous operations, AI solutions improve efficiency, accuracy, and accessibility when creating medical records. However, the integration of AI introduces obstacles and constraints that must be carefully addressed.

Pros of AI in Medical Writing

1. Data Analysis: Maximizing Efficiency

Manually searching through large scientific literature and datasets might be like looking for a needle in a haystack. AI in medical writing quickly analyses large amounts of scientific literature and data, revealing patterns, correlations, and trends that would be difficult to detect manually, so improving study quality. AI’s incorporation into medical writing for clinical trials represents a paradigm change towards a more data-driven and technologically advanced approach, hastening the distribution of crucial medical information and improving communication and decision-making processes in the healthcare industry. This has the potential to improve patient outcomes and overall healthcare quality. This capability has transformed the way healthcare practitioners extract knowledge, allowing stakeholders to gain greater insights into disease processes, treatment outcomes, and population health patterns, ultimately driving evidence-based practices and shaping healthcare policies. Furthermore, AI’s capacity to quickly analyse and summarise scientific material helps to increased research accessibility and understanding, by providing simple yet correct language patterns for enhanced clarity and readability.

2. Saves Time and Resources:

AI writing tools speed up a variety of writing processes, including drafting clinical study protocols, permission forms, and clinical reports; generating paperwork for regulatory filings; reviewing literature; and summarising research findings. The time and effort needed for manual writing tasks is greatly reduced by this automation, giving healthcare workers more time to devote to patient care and research projects. In the end, the increased effectiveness of AI in medical writing helps to reduce the time and expense associated with clinical trials while also hastening the distribution of vital medical information. Both parties benefit from the arrangement, which opens the door to improved healthcare results and more knowledgeable decision-making.

3. Personalization:

Nowadays a brochure, informed consent form, or study-specific educational resources are made just for the specific study or specific patient population. Thanks to AI medical writing tools, that personal touch is becoming the new norm. These innovative services help effectively tailor educational resources like brochures and consent forms to suit each patient’s individual needs.

4. Enhanced Efficiency:

AI writing tools can significantly improve efficiency by automating various writing tasks. These tools utilize advanced algorithms and natural language processing to generate error-free content quickly. The speed and accuracy of AI-powered tools can save writers valuable time, allowing them to focus on other aspects of their work.

5. Grammar and Spell Check:

AI writing tools excel in detecting grammatical errors and spelling mistakes. They can offer real-time suggestions and corrections, ensuring that the final content is error-free and professionally written. This feature is particularly beneficial for non-native English speakers or writers looking to enhance their language skills.

6. Plagiarism Detection:

Plagiarism is a serious concern in the writing industry. AI-powered tools have sophisticated algorithms that can identify plagiarized content by comparing it with vast databases of published work. This capability helps writers ensure the originality and authenticity of their content.

7. Language Enhancement:

AI writing tools can assist writers in improving their language skills and enhancing the overall quality of their content. These tools can suggest alternative phrasing, provide vocabulary suggestions, and offer insights into sentence structure and readability. Such features can help writers create polished and articulate pieces.

Cons of AI in Medical Writing

1. Potential for Bias and Inaccuracy

Despite AI’s ability to automate tasks, ensuring the accuracy and dependability of the content it produces remains a top priority. Due to the fact that AI chatbots rely on large language models (LLM), the responses they offer are a function or a derivative of their repertoire. As a result, there is a chance that these chatbots will skew scientific writing due to potential biases in the training datasets. Racial, sexual, or religious biases are examples of this, which would make the outcomes less inclusive.

Furthermore, artificial intelligence (AI) systems may generate inaccurate or misleading results when they encounter rare or foreign medical conditions for which they lack sufficient training data. Complex medical concepts, unusual or foreign medical conditions, and context-specific information requiring critical thinking or creative problem-solving skills may be challenging for AI systems to comprehend effectively, which could result in errors, misinformation, or erroneous output. Vigilant monitoring and validation processes are essential to reducing these hazards.

2. Over Reliance on AI

When AI is used excessively in medical writing, it can lead to technological reliance, which could reduce human oversight and minimise the significance of human expertise in preserving the caliber and applicability of medical information. AI systems might not have the contextual awareness, critical thinking, empathy, inventiveness, inclusivity, or ethical judgement that human writers do. Such an over-reliance on AI in medical writing could compromise its credibility, erode public confidence, and open the door for predatory publications to use AI for their own financial gain. This might result in the mass creation of false, deceptive, and low-quality content, further eroding the authority of academic journals.

3. Ethical Concerns

There are ethical questions with using AI in medical writing, especially when it comes to patient privacy and data security. Inadequate setup or administration of artificial intelligence systems may unintentionally reveal personal patient data or breach privacy regulations, jeopardising patient privacy. Protecting patient privacy is crucial since AI writing tools frequently process large amounts of data, including sensitive information.

Furthermore, there are still numerous unanswered legal problems around infringement and the regulations governing AI and copyright law. Artificial intelligence systems frequently incorporate data from multiple sources, such as databases and articles, raising concerns about who owns and has access to this aggregated data. Determining whether AI-generated work violates copyright rules and is original or a copy of something else is a difficult task. It is critical that there be clear frameworks and regulations to address copyright issues at a time when AI is being used more and more to create and distribute material since these ambiguous standards have compounded legal issues for those who create, utilise, and build AI.

4. Lack of Creativity:

While AI writing tools excel in generating error-free and coherent content, they often lack creativity and originality. These tools rely on existing data and patterns, limiting their ability to produce unique and innovative ideas. Therefore, if creativity is a crucial aspect of writing, AI tools may not be the best choice.

5. Contextual Understanding

AI-powered writing tools may struggle with understanding the context and nuance of certain topics. They can misinterpret specific phrases or fail to capture the intended meaning. Human writers, on the other hand, possess the ability to comprehend complex ideas, emotions, and cultural references, enabling them to produce content that resonates with readers on a deeper level.

6. Cost and Accessibility

AI writing tools, especially those with advanced features, often come with a price tag. Some writers may find these tools expensive, especially if they are just starting or have limited budgets. Additionally, not all writers may have access to reliable internet connections or the necessary hardware to use AI writing tools effectively.

The use of AI in medical writing has the potential to significantly improve productivity, accuracy, and accessibility. However, it also raises significant problems about quality, ethics, and overreliance. When deciding whether to use AI technologies in their medical writing practices, stakeholders must carefully balance the benefits and drawbacks.

Future developments in AI technology, together with ongoing improvements in legislative frameworks and data security measures, may alleviate some of the current constraints. Medical writers and healthcare organisations may make informed judgements about how to use AI to optimise their document creation processes while maintaining high quality and compliance standards by being aware and engaged with technical developments.

This blog will explore the importance of eDMS in the medical device industry, with a focus on how regulatory eDMS solutions help companies meet compliance requirements efficiently. If your company is navigating the complex landscape of regulatory submissions, audits, and quality management, a well-implemented eDMS can be your secret weapon.

What is eDMS in the Medical Device Industry?

Defining eDMS

An electronic Document Management System (eDMS) is a software solution designed to manage, store, track, and share electronic documents in a secure environment. In the medical device sector, an eDMS is not just a repository for documents—it plays a critical role in ensuring that all documentation related to the design, manufacture, testing, and regulation of medical devices is properly organized and accessible for audits, approvals, and regulatory submissions.

Regulatory eDMS

A regulatory eDMS is a specialized type of eDMS that focuses on managing documents needed for regulatory compliance, such as submissions to the FDA, European Medicines Agency (EMA), and other global regulatory bodies. This system helps medical device companies manage regulatory documents efficiently, ensuring that they adhere to the standards required by governing bodies.

The Importance of Regulatory eDMS in Medical Devices

Ensuring Compliance with Regulatory Standards

Medical device companies must comply with a wide array of regulations, including FDA 21 CFR Part 11, ISO 13485, and the EU Medical Device Regulation (MDR). These regulations require companies to maintain detailed records of device development, clinical trials, quality assurance processes, and more. A regulatory eDMS ensures that all these documents are stored securely and are readily accessible for regulatory reviews or audits.

Streamlining Regulatory Submissions

Submitting regulatory documentation is one of the most time-consuming tasks in the medical device industry. A regulatory eDMS simplifies the process by automating document workflows, maintaining version control, and ensuring that documents meet the specific formatting and content requirements of various regulatory bodies.

For example, when submitting a premarket approval (PMA) to the FDA, a regulatory eDMS can ensure that all necessary documentation is compiled accurately, reducing the risk of delays caused by missing or incorrect information.

Key Features of an Effective eDMS for Medical Devices

1. Document Version Control

Medical device development involves a series of iterations, revisions, and updates to design and manufacturing documents. An eDMS system must provide robust version control to track these changes. This ensures that teams are always working with the latest version of a document, reducing confusion and the risk of non-compliance.

2. Automated Workflows

Automating workflows is a game-changer for regulatory compliance. With an eDMS, tasks like document approvals, reviews, and submissions can be automated, ensuring timely completion and reducing the administrative burden. Automated workflows also allow for clear tracking of who accessed or edited a document, ensuring accountability.

3. Audit Trails

Regulatory bodies require thorough audit trails to confirm that changes to documents are tracked and recorded properly. An eDMS provides an electronic log of every interaction with a document – when it was created, edited, approved, or shared—allowing for complete transparency and traceability.

4. Secure Access and Permissions

Given the sensitive nature of regulatory documents, it is vital that an eDMS offers role-based access control. This means that only authorized personnel can access or modify certain documents, safeguarding against unauthorized changes and protecting intellectual property.

How eDMS Enhances Regulatory Compliance for Medical Devices

Managing Regulatory Documents Efficiently

In the medical device industry, regulatory submissions require extensive documentation, including design dossiers, risk management reports, and clinical evaluations. A regulatory eDMS ensures that all required documents are organized and accessible, making the submission process more efficient and reducing the risk of delays due to missing documentation.

Supporting Global Compliance

For medical device companies operating in multiple markets, compliance with various international regulations can be challenging. Regulatory requirements vary significantly across regions, such as the FDA’s requirements in the United States versus the MDR in the European Union. A regulatory eDMS can be configured to support different sets of regulations, helping companies maintain compliance across multiple markets simultaneously.

Facilitating Faster Audits and Inspections

Regulatory bodies frequently conduct audits and inspections to ensure compliance with relevant standards. With a regulatory eDMS, audit trails, document versions, and submission records are easily accessible, making it faster and more straightforward to respond to audits and inspections. The ability to produce the right document quickly and demonstrate regulatory adherence can significantly improve audit outcomes.

Benefits of Implementing eDMS for Medical Devices

1. Increased Efficiency

Manual document management processes are often inefficient and prone to error. With an eDMS, medical device companies can significantly reduce the time spent on document handling, approvals, and submissions. Automated workflows and electronic submissions reduce the administrative workload, allowing teams to focus on product innovation and development.

2. Improved Collaboration

In a globally dispersed industry, teams across multiple locations need access to the same documents. A cloud-based eDMS allows seamless collaboration between different teams, ensuring that everyone has access to up-to-date regulatory documents. This eliminates the delays caused by sharing documents via email or physical copies and ensures everyone is on the same page.

3. Reduced Risk of Non-Compliance

One of the biggest risks in the medical device industry is non-compliance, which can lead to costly recalls, fines, or even legal action. An eDMS reduces this risk by maintaining accurate, up-to-date records of all regulatory documents. Automated workflows ensure that necessary approvals are obtained, and audit trails provide the transparency needed to prove compliance.

4. Cost Savings

While implementing an eDMS requires an initial investment, the long-term cost savings are significant. By reducing the time spent on manual document management, automating workflows, and minimizing the risk of regulatory penalties, medical device companies can save both time and money.

Challenges of Implementing eDMS in Medical Device Companies

1. Initial Setup and Configuration

Implementing an eDMS can be complex, particularly for companies that are new to electronic systems or have extensive legacy documentation. The initial setup requires careful planning, including digitizing existing documents, configuring workflows, and training staff.

2. Change Management

Transitioning from a paper-based or hybrid document management system to a fully electronic system can be a cultural shift for some organizations. Ensuring that staff are adequately trained and that there is buy-in from all levels of the organization is critical to the successful implementation of an eDMS.

3. Integration with Existing Systems

For an eDMS to be effective, it needs to integrate with other systems used in the product lifecycle, such as Quality Management Systems (QMS), Enterprise Resource Planning (ERP), and Clinical Trial Management Systems (CTMS). Ensuring seamless integration between these systems is essential for maximizing the benefits of an eDMS.

How to Choose the Right eDMS for Regulatory Compliance

Assess Your Specific Needs

Not all eDMS platforms are created equal. Medical device companies need to choose a system that aligns with their specific regulatory requirements and business processes. Consider factors like the scale of your operations, the number of users, and the level of customization needed.

Evaluate Features for Regulatory Compliance

Ensure that the eDMS you choose offers features like version control, audit trails, secure access, and regulatory submission management. These are essential for ensuring compliance and avoiding potential regulatory issues down the line.

Consider Cloud-Based Solutions

Many medical device companies are opting for cloud-based eDMS solutions, which offer greater flexibility, scalability, and cost savings compared to on-premises systems. Cloud-based systems are particularly advantageous for companies with global operations, as they allow for real-time collaboration and easy access to documents from anywhere in the world.

The Future of eDMS in the Medical Device Industry

AI and Automation

As technology continues to evolve, eDMS systems are likely to incorporate more AI and automation features. These advancements could include automated document generation, predictive analytics for regulatory submissions, and AI-powered compliance monitoring.

Blockchain for Document Security

Blockchain technology has the potential to revolutionize the way documents are managed and secured. In the future, blockchain could be integrated into eDMS systems to provide an immutable, decentralized record of document versions and audit trails, further enhancing security and transparency.

Conclusion

An eDMS is more than just a digital filing cabinet – it’s a powerful tool that can transform the way medical device companies manage regulatory compliance. From ensuring accurate document version control to automating workflows and supporting global compliance, a well-implemented eDMS can help organizations stay competitive, compliant, and efficient in today’s fast-paced regulatory environment.

In general, an eIFU is defined as a non-paper version of the instructions for use. Currently, the definition of an eIFU is not the same in each market.

In the EU, according to the Commission Implementing Regulation EU 2021/2226, which laid down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council in regards to electronic instructions for use of medical devices, instructions for use in electronic format means “instructions for use displayed in electronic form by the device, contained in portable electronic storage media supplied by the manufacturer together with the device, or made available through software or website.”

European eLabeling regulation 2021/2226 

The Medical Device Regulation (MDR) introduces a comprehensive framework that integrates multiple electronic instructions for use (eIFU) requirements, further supplemented by Implementing Regulation (EU) 2021/2226, the successor to Commission Regulation (EU) 207/2012.

Requirements for the use of electronic instructions for use as per regulation (EU) 2021/2226 

According to Implementing Regulation (EU) 2021/2226, instructions for use may be provided electronically (eIFU) instead of on paper if certain conditions are met:

1. The device should fall into a specific class, as mentioned below:
   • Implantable and active implantable medical devices and their accessories
   • Fixed installed medical devices and their accessories
   • Medical devices and their accessories fitted with a built-in system visually displaying the instructions for use (e.g., ultrasound equipment)
2. The devices and accessories are intended for exclusive use by professional users
3. The use by other  people is not reasonably foreseeable
4. For software, manufacturers may provide eIFUs within the software itself.

Manufacturers of Medical devices 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:

• Knowledge and experience of the intended users in particular regarding the use of the device and user needs;
• Characteristics of the environment in which the device will be used;
• knowledge and experience of the intended user of the hardware and software needed to display the instructions for use in electronic form;
• Access of the user to the reasonably foreseeable electronic resources needed at the time of use;
• Performance of safeguards to ensure that the electronic data and content are protected from tampering;
• Safety and backup mechanisms in the event of a hardware or software fault, particularly if the instructions for use in electronic form are integrated within the device;
• Foreseeable medical emergency situations requiring the provision of information in paper form;
• Impact caused by the temporary unavailability of the specific website, 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;
• Evaluation of the period within which the instructions for use shall be provided in paper form at the user’s request;
• Assessment of the website’s compatibility with displaying the electronic instructions for use with different devices that could be used to display those instructions;
• Management of different versions of the instructions for use, where applicable

Factors to consider when switching to an electronic IFU for your medical device

1. Risk assessment

eIFU must maintain or improve the level of safety compared to providing a paper IFU. Your risk assessment needs to examine this carefully. For instance, if your device is sometimes used by nurses or doctors in rural locations where the internet may be spotty, what additional risks might that present? You will need to update your risk management procedures and forms to account for this.

2. Product packaging

The location of the eIFU must be indicated on the packaging for each unit or, in the case of fixed devices, on the device itself. For obvious reasons, you cannot simply place PDFs of your IFU on your website and assume professional users will know to look there. The Regulation makes it clear that your packaging must clearly specify that the IFU is in electronic format and where it can be found. Except for software and devices with screens, the IFU may reside on a website, and its location may be communicated via a website URL or QR code. If you choose the latter, make sure you document the pros and cons of using QR codes in your risk assessment and update your labeling work instructions as needed.

3. Validation

Ensure the user’s access is precise by having accurate product data in real-time and a solution for delivering the information in the user’s preferred language.

4. Method of delivery

If you make software as a medical device (SaMD) or a device with a larger display screen, the method of delivery may be the device itself. For all other devices, device manufacturers will most likely deliver IFUs via their website. This fulfills a key requirement that the information be provided in a universally available format (thumb drives and DVDs are no longer universal). The preamble of the new eIFU regulation says, “To ensure unconditional access to the instructions for use in electronic form and to facilitate the communication of updates, those instructions should be available on the website of the manufacturer in an official language of the Union determined by the Member State in which the device is made available to the user or patient.” This does not mean you cannot deliver your eIFU on a private YouTube channel, for example.

5. Paper version

There are professionals out there who prefer paper-based instructions, or (it is true) might not have reliable internet access. It is EU law to have paper IFUs, with the exception of some devices. If a paper-based option is required, you are obligated to provide a paper version within seven calendar days of the request at no cost. In cases where video or animation is not used, the eIFU may simply be a printed copy of the PDF you maintain online. Make sure to update your labeling SOP with this requirement.

6. Online security

Making your IFU available online is easy. Ensuring that it does not accidentally get removed or replaced is not possible. You will need to put procedures in place to ensure that your sales and marketing departments do not change the URL, delete old versions, or otherwise change the document. You should really think of the master IFU web page(s) as controlled documents, not just the IFU itself.

7. Archival procedures

For devices without a defined expiration date, your IFU needs to be maintained for 15 years after the last device has been placed on the market. For devices with an expiration date, this changes to 10 years. You also need to have a system for indicating when changes have been made (change control) and a way to inform each user if the change was made for safety reasons. Finally, all historical versions of the IFU must be made available on the website.

8. Privacy policy

Europe has one of the strictest online privacy laws in the world, known simply as the GDPR (General Data Protection Regulation 2016/679). If you will be asking the user to provide their name and/or email, or if your website has cookies enabled (most do), you will need to make sure you are following the GDPR.

Advantages of eIFU over paper-based instructions:

• Enhanced accessibility: considering the high internet coverage, electronic instructions can be accessed digitally and consulted anywhere, providing easier search and navigation and greater flexibility.
• Real-time updates: eIFU allows for immediate updates and revisions, ensuring that users always have the latest information about the product they are using. This is crucial for patient safety and optimal device utilization.
• User-friendly interfaces: Electronic formats enable the incorporation of multimedia elements, such as videos and interactive features, enhancing the clarity and effectiveness of instructions.
• Increased efficiency in MDR implementation: electronic formats facilitate the inclusion of multiple languages and therefore contribute to reducing the risk of shortages of medical devices and improving the overall availability of these devices, especially in a multilingual context like the European Union.
• Cost efficiency: Over time, the implementation of eIFU can lead to cost savings for both manufacturers and healthcare institutions, as the need for printing, distribution, storage, and waste management of paper IFU is significantly reduced.
• Environmentally sustainable: The transition to eIFU aligns with broader efforts to reduce paper usage, contributing to environmental sustainability and supporting the EU Green Deal.

Going forward, manufacturers seeking to sell their products in the European market must comply with the EU eIFU regulations. Adhering to these regulations will provide greater flexibility and reduce the risk of product recalls related to IFUs. If you are in the process of updating your device labels and preparing eIFUs, feel free to contact DDi for expert assistance.

Purpose of Vigilance System

Principal purpose of the Medical Device Vigilance System is to improve the protection of health and safety of patients, USERs and others by reducing the likelihood of reoccurrence of the INCIDENT elsewhere. This is to be achieved by the evaluation of reported INCIDENTs and, where appropriate, dissemination of information, which could be used to prevent such repetitions, or to alleviate the consequences of such INCIDENTs.

Medical Device Vigilance System includes:

1. Manufacturers

2. National Competent Authorities (NCA)

3. The European Commission

4. Notified Bodies

5. USERs and others concerned with the continuing safety of MEDICAL DEVICEs

What are Vigilance requirements?

Vigilance requirements includes Incident Reporting System using PSUR’s, FSCA’s, FSN’s, MIR’s, Trend Reports and PSR’s.

Definitions:

Periodic Safety Update Report (PSUR): The main objective of a PSUR is to present a summary of the results and conclusions of the analyses of post-market surveillance data relating to a device or a device group, thus allowing the reporting of any possible changes to the benefit-risk profile of the medical device(s), considering new or emerging information in the context of cumulative information on benefits and risks.

Field Safety Corrective Action (FSCA): A ‘Field Safety Corrective Action (FSCA)’ is a corrective action taken by a manufacturer for technical or medical reasons to either prevent or reduce the risk of a serious incident, which is associated with a device that is made available on the market.

Field Safety Notice (FSN): A ‘Field Safety Notice (FSN)’ is a communication sent by a manufacturer to users or customers in relation to a field safety corrective action.

Trend Report: Any statistically significant increase in the frequency or severity of incidents that are not serious incidents or that are expected undesirable side-effects that could have a significant impact on the benefit-risk analysis and which have led or may lead to risks to the health or safety of patients, users or other persons that are unacceptable when weighed against the intended benefits. The significant increase shall be established in comparison to the foreseeable frequency or severity of such incidents in respect of the device, or category or group of devices, in question during a specific period as specified in the technical documentation and product information.

Periodic Summary Report (PSR): A ‘Periodic summary report’ (PSR) is an alternative reporting regime by which the manufacturer, in agreement with the respective national competent authority that is coordinating the periodic summary reporting (and in consultation with the competent authorities referred to in Article 92(8) (a) MDR), can report similar serious incidents with the same device or device type in a consolidated way. Criteria for periodic summary reporting include situations where; the root cause has been identified, a FSCA has been implemented or where the serious incidents are common and well documented.

Submission of Vigilance Requirements in EUDAMED:

PSUR

Step 1: Preparation of PSUR

The PSUR preparation and issuance timeline refers to the period required for the manufacturer to prepare and submit PSUR (for Class III, Class IIa and Class IIb implantable devices according to Article 86) to the Notified Body via EUDAMED or make it available to the Notified Body after the end of the data collection period.

Step 2: Registering a PSUR in EUDAMED using PSUR Web Form for Manufacturer

The PSUR Web form for manufacturer contains all the relevant administrative data necessary for the registration of the PSUR in EUDAMED: certain fields are automatically populated by EUDAMED e.g. Notified Body, Manufacturer, Single Registration Number (SRN) while other data need to be filled up by the manufacturer via EUDAMED Web interface

The manufacturer should create a PSUR reference number which should remain the same for the PSUR updates. In case of grouping of devices within one PSUR, the PSUR reference number relates to the leading device.

When registering a PSUR in EUDAMED, the manufacturer should capture the Basic UDI-DIs of all the Class III or implantable devices belonging to the group via the web interface.

Step 3: Submission of PSUR

Depending on the class of the device and in accordance with Article 86(2), the manufacturer should either submit the PSUR to the Notified Body via EUDAMED or make it available to the Notified Body involved in the conformity assessment.

When EUDAMED becomes fully functional, the manufacturer should upload the PSUR in PDF format into EUDAMED for MDR class III devices or implantable devices and provide the information* of the PSUR Web form directly through the EUDAMED Web interface.

FSCA, FSN, MIR, PSR:

Step 1: Reporting of Serious Incidents and Field Safety Corrective Actions

Manufacturers of devices made available on the Union market, other than investigational devices, shall report, to the relevant competent authorities, in accordance with Articles 92(5) and (7), the following:

a) Any serious incident involving devices made available on the Union market, except expected side-effects which are clearly documented in the product
information and quantified in the technical documentation and are subject to trend reporting pursuant to Article 88;

b) Any field safety corrective action in respect of devices made available on the Union market, including any field safety corrective action undertaken in a third country in relation to a device which is also legally made available on the Union market, if the reason for the field safety corrective action is not limited to the device made available  in the third country.

c) For similar serious incidents that occur with the same device or device type and for which the root cause has been identified or a field safety corrective action  implemented or where the incidents are common and well documented, the manufacturer may provide periodic summary reports instead of individual serious incident       reports, on condition that the coordinating competent authority

• Manufacturers should report serious incidents and field safety corrective actions to the respective/relevant national vigilance systems. The new MIR form has already been adapted to MDR requirements and should be used accordingly.
• The current FSCA form should be used (the additional information required under the MDR may be added to the general comments section of the form).

The reporting timelines outlined in the MDR are the following:

1. Any serious incident, that did not involve a death or an unanticipated serious deterioration in a person’s state of health, must be reported immediately after a causal relationship between device and the serious incident has been established or is reasonably possible and no later than 15 days after the awareness date of the serious incident (Article 87(3) MDR),

2. A serious public health threat must be reported immediately, and not later than 2 days after the manufacturer becomes aware of that threat (Article 87(4) MDR),

3. Death or an unanticipated serious deterioration in a person’s state of health must be reported immediately after a causal relationship between the device and the serious incident is established or as soon as such relationship is suspected, and no later than 10 days after the awareness date of the serious incident (Article 87(5) MDR).

Trend Reporting

Manufacturers shall report, by means of the electronic system referred to in Article 92, any statistically significant increase in the frequency or severity of incidents that are not serious incidents or that are expected undesirable side- effects that could have a significant impact on the benefit-risk analysis referred to in Sections 1 and 5 of Annex I and which have led or may lead to risks to the health or safety of patients, users or other persons that are unacceptable when weighed against the intended benefits.

Step 2: Analysis of Serious Incidents and Field Safety Corrective Actions

• Manufacturers should submit the final report to the respective / relevant national vigilance system.
• Communication with other competent authorities should take place through a dedicated secure directory in CircaBC (organised by the Commission) for MDR devices.
• For Legacy and older devices, the existing Eudamed2 system for NCAR should continue to apply
• Manufacturers should submit the field safety notices to the respective/relevant national vigilance systems.
• The respective/relevant competent authorities should make these field safety notices publicly available/accessible to the public in accordance with theirnational legislation.
• The coordinating competent authority shall inform by email or other suitable communication channels, the other competent authorities, the manufacturer and the Commission that it has assumed the role of coordinating competent authority

Step 3: Submission of FSCA, FSN, Trend Report, PSR and MIR

The use of the new MIR form has been mandatory since January 2020 and as a general rule, we advise sending both the PDF and XML to national Competent Authorities as not all Member States will adopt the new XML (XSD) schema.

FSCA, FSN, Trend Report, PSR can be send in both PDF and XML to national Competent Authorities as not all Member States will adopt the new XML (XSD) schema.

*The templates of FSCA, FSN, Trend Report and PSR reports are not updated as per MDR, the additional information required under the MDR may be added to the general comments section of the form.

For EUDAMED solutions like UDI, Vigilance, ViSU has modules for these to automate. Please reach out to us in case if you want to review or discuss these solutions