Companies not organized on information management with a system will end up duplicating lot of activities leading to loss of productivity and increase risk of non-compliance.

There are 3 categories of Challenges grouped by:

Process Challenges:

Training must be required to simplify the complexity of multiple system & user interface. As a result, users work outside of the system using local file shares or email to collaborate. To check the work status and to create report most of the companies depends on separate reporting tool or manual spreadsheets.

System Challenges:

Medical device regulation is much versatile. Upgrading a system with updated integrations is challenging and expensive as well. Systems that lie behind corporate firewalls are difficult to outsource to business partners or service providers.

Compliance Challenges:

Users develop manual tracking spreadsheets when planning & tracking capabilities aren’t part of a content management system. Many times users share information and documents via email that cause inconsistent use of document template and it is much difficult to Re-import.

Importance of a RIM system

Medical device registrations differ from country to country, with the difference in FDA’s 510K (Class I and II devices) and Premarket Approval (Class III devices) processes from the EU’s CE Marking process. The current regulatory environment in which the medical devices and diagnostics companies are competing is complex.

There is a higher demand for regulatory and compliance information required to support submissions 510 (k), PMA, De Novo and HDE.A cloud based RIM can effectively help management of product registration, commitments and regulatory submissions to medical device and diagnostics companies. This unified, single-source system provides a global user base with real-time information necessary to ensure the quality of the product and the registration.

Following capabilities should be present in an effective regulatory information management system:

•  Identifies device-specific global regulatory requirements.
•  Assembles product information into country-specific TF template.
•  Controls the dossier configurations for internal review and external review.
•  Manages changes and revisions to TFs and product information.
•  Generates compliant submission documents in various HA/NB formats.
•  Tracks & retains submission status & manage commitments.
•  Decreases effort and calendar time to replicate regulatory submission between products and regulatory agencies.
•  Provides clear oversight of original and lifecycle submissions.

RIM in future

With the versatile and novel reporting requirements set out by regulatory authorities, the plea to need Regulatory Information Management System (RIM) is emerging brassier. The medical device market is progressively adopting regulations for UDI, eIFU, electronic submissions, others. Making these things happen without a proper RIM system is very challenging.

At the same time, Medical device companies themselves are now realizing the strategically important role that various forms of product data could play in the future; enhancing new productivity, efficiency and create competitive differentiation.

A proper Regulatory & Submission management tool can help minimize pain. A cloud-based intuitive system increases productivity and efficiency as well while maintaining proper compliance

Some Benefits of Regulatory system:

If you want to explore what features will benefit you, please do a ViSU demo and decide if it’s a value or not to your company

EU MDR is turning digitization on its head. This new regulation, which goes into effect May 26, 2020, is inducing digitization back to the forefront. EU MDR aim to enhance medical device safety and effectiveness and to realize this, the new regulation requires the use of eIFU.

eIFU: Meaningful Requirement Improving Patient Safety

European MDR makes eIFU a requirement while supercharging it with a meaningful value proposition. eIFU improves patient safety by providing users with the most up-to-date information in their preferred language. In addition, eIFU can include video and audio files, making it easy to demonstrate operating and handling instructions through mobile devices. And, time to market with revisions or changes is much faster via electronic distribution; ensuring users access the most accurate information.

Complying with eIFU Requirements

To comply with and exploit the benefits of eIFU, a manufacturer should primarily complete a documented risk assessment that demonstrates eIFU maintains or increases safety compared to traditional IFU. Some of the additional requirements include:

• Clearly specify on the product packaging of each unit that the instructions for use are provided in electronic rather than paper form. If it is a fixed medical device, this information should appear on the device itself.
• Provide eIFUs in a universally available format and include information on the hardware and software requirements required to display them.
• Develop alternate plan for users who do not have Internet access by providing a paper copy, upon request, of the IFU within seven days at no extra cost to the user.
• Ensure eIFUs are available for at least two years after the expiry date of the last produced device or 15 years after the last manufactured device in case of implantable devices or devices without a defined expiry date.

Compliance with EU MDR and eIFU need major process redesign for many manufacturers. Documented risk assessments and quality management systems are a must for eIFU. If a manufacturer is considering outsourcing its eIFU, it is the sole responsibility of the manufacturer to maintain safety over the products, including supplemental materials according to new European Medical Device Regulations.

Manufacturers must ensure the information user access is precise. This means having accurate product data in real time and a solution for delivering the information in the user’s preferred language.

As digital enablement will soon be a requirement under MDR, manufacturers need a system like VISU with a centralized product repository with access to global product information and web based eIFU multi language portal to manage IFU updation and distribution globally, enabling the promise of improved patient safety and engagement is within reach.