Alarming results and some good news from MDR and IVDR survey of notified bodies

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By Annette Van Raamsdonk and Evangeline Loh, Emergo by UL

The European Commission (EC) posted a July 25 update on the current state of Medical Devices Regulation (2017/745 MDR) and In Vitro Diagnostics Devices Regulation (2017/746 IVDR) applications.

The data collected was from a recent survey instrument intended to monitor and analyze the availability of devices on the EU market.

Study on medical devices and Notified Body survey instrument

The study was led by Gesundheit Österreich GmbH (Austrian National Public Health Institute) with Areté and Civic Consulting. The study started in December 2022 and will end in 2025.

The survey instrument to collect the most recent data on certificates issued and the number of applications received was shared with the Notified Bodies on April 3, 2023, and concluded May 5, 2023.

The collected data have been compared with data…

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What does the future of AI hold for medical device usability testing?

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Medical device usability testing and the emergence of artificial intelligence

By Nye Canham and Dhanial Salim, Emergo by UL

Usability testing is a mainstay in the application of human factors engineering (HFE) to medical device design. However, while regulatory requirements for usability testing keep developing, the application of usability testing in the medical industry has remained fundamentally unchanged since its adoption.

With the release of generative artificial intelligence (AI) chatbots bringing AI to the forefront of public attention and continued fast-paced technical innovation in the medical industry, current approaches to usability testing may begin to appear antiquated. Furthermore, it brings into question whether traditional usability testing approaches can keep pace and remain effective tools t…

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FDA warns of cybersecurity risk in certain medical device software components

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Kathryn Burke, Emergo by UL

The U.S. Food and Drug Administration (FDA) has issued a cybersecurity alert to medical device manufacturers regarding vulnerabilities that have been identified in the Axeda agent and Axeda Desktop Server.

The FDA alert noted that all versions of Axeda agent and Axeda Desktop Server are affected. The agent and desktop server are owned and supported by computer software company PTC and are used in a number of medical devices across several medical device manufacturers.

Get the full story here at the Emergo by UL’s blog.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of or its employees.


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European IVDR application partially postponed

Ronald Boumans, Emergo by UL

The European Commission has proposed delaying compliance deadlines for the In-vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR), which would allow some manufacturers more time to prepare for compliance to the new Regulation and secure Notified Body support.

Get the full story here at the Emergo Group’s blog.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of or its employees.

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Emergo by UL, MedCrypt pair on cybersecurity

Emergo by UL and MedCrypt will jointly offer cybersecurity risk management and mitigation for connected medical devices and systems.

Medtech and healthcare technology consulting group Emergo and healthcare cybersecurity developer MedCrypt said this week that they will refer prospective clients to one another and co-market their cybersecurity software solutions, consulting and risk management services to ensure clients understand and meet the FDA’s requirements and those of other market regulators.

Get the full story on our sister site, Medical Design & Outsourcing.

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