All Regulatory Rapporteur articles in October 2022

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    Article

    The health economics profile of new pharmaceuticals

    2022-09-16T09:26:00Z

    The current article discusses elements of the health economics profile of new pharmaceuticals, specifically looking at the challenges of providing a healthcare system, the concepts around the provision of value-based healthcare systems and calculating the cost-effectiveness of new medicines. A quality-adjusted life year (QALY) is a concept used in health ...

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    Editorial

    October 2022 Editorial: Great expectations for medical technologies

    2022-09-16T09:26:00Z

    Few would dispute that the medical technology regulatory system continues to creak under the strain imposed by the regulations on medical devices (Regulation (EU) 2017/745) and in vitro diagnostic devices (Regulation (EU) 2017/746). At the time of going to print, the Medical Device Coordination Group (MDCG) issued proposed ...

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    Article

    Navigating the MDR’s heightened surveillance and performance requirements

    2022-09-16T09:25:00Z

    Substantial changes to post-market surveillance, post-market clinical follow-up and the new requirement to include a summary of safety and clinical performance, have all placed greater obligations on medical device manufacturers. The changes introduced by the Medical Device Regulation (MDR), have the overarching objective of improving patient safety and providing greater ...

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    Article

    The importance of subjective and qualitative risk management for medical devices regulation

    2022-09-16T09:25:00Z

    In the early 2000s, risk management was thought to be able to offer the medical devices industry an exponential game-changing quality revolution. The developments brought by the Japanese quality philosophy, or total quality management, had seen many industries − such as aerospace and automobile production – make a paradigm shift ...

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    Article

    EU expert panels for high-risk devices - another level of review?

    2022-09-16T09:25:00Z

    The new EU regulations for medical device and in vitro diagnostic devices called for additional expert reviews for novel and high-risk devices. These newly formed committees have published three opinions for medical devices and fifteen opinions for IVDs. The opinions offer a detailed and critical review of data from both ...

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    Article

    The new UK MDR - a great start to a long road ahead

    2022-09-16T09:25:00Z

    On 29 March 2017, the UK invoked Article 50 of the Treaty on European Union (EU)[1] and began the withdrawal process from the EU. Despite the UK’s departure from the EU on 31 January 2020, EU legislation continues to apply in UK domestic law. This means that, for the medical ...

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