The impact of regulation and AI on Europe's medical device trial landscape

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The impact of regulation and AI on Europe's medical device trial landscape

The upcoming Outsourcing in Clinical Trials: Medical Devices Europe 2025 conference in Munich will address the significant impact of the EU Medical Device Regulation (MDR) on medtech companies. Introduced in 2017, the MDR aims to enhance medical device safety, with compliance deadlines set for 2024 through 2028. The conference will explore the challenges and requirements posed by the MDR, particularly in relation to clinical data and market approval.

A key focus will be the intersection of the EU AI Act and the MDR, highlighting how these regulations can coexist to foster innovation while ensuring safety. Experts from various companies, including Philips and TV AI.Lab, will discuss agile certification processes that streamline compliance for AI technologies. The evolving relationship between contract research organizations and medical device manufacturers will also be examined, emphasizing the role of AI in improving clinical trial efficiency.

• The EU MDR introduces complex compliance requirements for medical device manufacturers.

• AI technologies are crucial for enhancing clinical trial design and efficiency.

Key AI Terms Mentioned in this Article

EU MDR

The EU Medical Device Regulation sets stringent safety and compliance standards for medical devices.

EU AI Act

The EU AI Act outlines regulations for the development and deployment of AI technologies in various sectors.

Agile Certification

Agile certification processes aim to streamline compliance for AI medical devices under the MDR.

Companies Mentioned in this Article

Philips

Philips is a global leader in health technology, focusing on innovative medical devices and AI solutions.

TV AI.Lab

Lab specializes in the agile certification of AI medical devices, facilitating compliance with EU regulations.

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