A new cloud-based assessment support tool being developed by DNV could streamline the 3rd party assessment of medical devices in the EU, helping alleviate critical capacity issues in the regulatory system.
The regulatory landscape for medical technologies in the EU is undergoing a massive overhaul with the introduction of the Medical Device Regulation and In Vitro Diagnostic Regulation. In response to notable safety and quality issues, these new regulations introduce more stringent requirements on manufacturers to ensure the safety and performance of medical devices.
One cornerstone of the new regulatory regime is the expanded activities of the EU notified bodies, which are independent 3rd parties responsible for assessing these devices prior to being placed on the market. Despite the envisioned benefits of this new system, implementation has been challenging. Critically, both the ability of manufacturers to fulfil the new requirements and the limited capacity of notified bodies have been substantial bottlenecks, which are beginning to affect the availability of medical devices in the EU market.
Modern, cloud-based assessor support tools
Axxessment:AI is a modern, cloud-based assessment support tool meant to aid DNV medical device assessors. Using Axxessment:AI, assessors can quickly access regulatory guidance specific to the type of device they are assessing. It provides intuitive tools to help manage, track, and categorize the documents a submission relies on, to draft and manage findings, and to check the completeness of an assessment. Axxessment:AI is delivered through a modern, secure web-app with a focus on user experience and is built with an extensible architecture that can be easily expanded beyond the initial pilot on standalone AI software medical devices, to other devices and even other regulations.
The benefits
By providing better digital systems for managing assessments, Axxessment:AI aims to reduce the time spent on tedious tasks such as combing through regulatory documents or managing documentation, allowing DNV assessors to focus on the critical tasks of evaluating evidence and applying their expert knowledge. This project aims to both improve the experience of assessors at DNV, and the efficiency with which they can assess and re-assess medical devices.
Market potential
Through more efficient, digitalized internal processes, DNV will generate additional capacity to support manufacturers and help alleviate the regulatory bottlenecks in the EU system. Ultimately, this will support manufacturers, who often face a long regulatory approval process, and ensure that critical life-saving technologies are made available to hospitals and patients in the EU. Axxessment:AI is currently in a pilot phase, and has the potential to be used as an assessor support tool for both other medical use cases, as well as other use cases relying on 3rd party assessment.
