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Relevance of state of the art (SOTA) considerations for product development

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Establishing the generally acknowledged state of the art is a key aspect of the clinical evaluation process for any medical device. Even though the MDR does not define what the state of the art encompasses or provide guidance on the methodology for its establishment, it is evident that state of...
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The European Artificial Intelligence Act and its challenges at the intersection of innovation and regulation

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Artificial intelligence is poised to transform healthcare by expediting the digitalisation of medical devices. Predictions say the use of AI in medical devices is anticipated to proliferate worldwide in the coming years, while regulatory-wise, the world's attention has also been focused on the...
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In-house IVD manufacturers, is your QMS IVDR ready?

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In-house IVDs (also referred to as Laboratory Developed Tests, LDTs) manufactured and used within a single health institution are regulated products under the IVDR. While a CE mark is still not necessary, in-house IVD manufacturers are required to establish an “appropriate” Quality Management...
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The presumed burden of post-market clinical data

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As everyone is now aware, post-market clinical evidence for medical devices sold in Europe must be regularly collected and assessed. The EU Medical Device Regulation 2017/745 (MDR) demands an increased level of scrutiny of medical devices by notified bodies to guarantee their safety and...
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Intended purpose: The compass of your market strategy

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When bringing a medical device to the market, the definition of its intended purpose is paramount. But what makes this intended purpose, also known as intended use, so vital for your business? Just as a compass helps travellers find their way, the intended purpose of a medical device directs...
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Clinical evaluation routes with limited clinical evidence

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The Medical Device Regulation (MDR) has heightened the standards for clinical evidence, yet ambiguities persist regarding specific requirements. This article delves into the clinical evaluation routes outlined by the MDR, focusing on scenarios where limited clinical evidence suffices for...
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When does software qualify as a medical device?

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With fast-developing technologies, software products have become essential to the healthcare industry. While the technical development of innovative software may be relatively quick, gaining market access for a software product within the scope of medical device regulations is no walk in the park....
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Summary of Safety and Clinical Performance: Plain language and health literacy principles

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Creation of the Summary of Safety and Clinical Performance (SSCP) is a new requirement under the Medical Device Regulation 2017/745 (MDR) for implantable and class III devices. It is a publicly available and objective summary of the clinical evaluation, tailored to address the intended users and...
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The importance of clinical evaluation planning

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With the introduction of the Medical Device Regulation 2017/745 (MDR), the regulatory requirements for the clinical documentation of medical devices have become more challenging. Uncertainties persist about how to precisely follow the newly introduced rules, worsened by variations in how different...
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