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The New European Medical Device Regulation: Balancing Innovation and Patient Safety

ANNALS OF INTERNAL MEDICINE (2023)

Preparing healthcare, academic institutions, and notified bodies for their involvement in the innovation of medical devices under the new European regulation

Francesco Garzotto et al.

Summary: The new European Medical Device Regulation (MDR) will have significant implications on the development and availability of new devices, potentially discouraging research investments in Europe. This poses a challenge for start-ups and small companies, and highlights the need for collaboration among stakeholders to enhance overall health and quality of life.

EXPERT REVIEW OF MEDICAL DEVICES (2022)

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Article Orthopedics

Improved clinical investigation and evaluation of high-risk medical devices: the rationale and objectives of CORE-MD (Coordinating Research and Evidence for Medical Devices)

A. G. Fraser et al.

Summary: In the EU, the management of medical devices involves collaboration between various authorities, including approval by the European Medicines Agency, conformity assessment by independent bodies, and clinical research. The latest Medical Device Regulation, in effect since 2021, provides general principles for evaluating and approving medical devices, but faces challenges in methodological details.

EFORT OPEN REVIEWS (2021)

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Article Health Policy & Services

Neither protective nor harmonized: the crossborder regulation of medical devices in the EU

Holly Jarman et al.

Summary: The European Union is facing challenges with inadequate regulation of medical devices, despite some improvements made. The underlying issues of market fragmentation and patient safety persist, posing significant consequences for health in Europe if strong support for the implementation of new directives is not provided.

HEALTH ECONOMICS POLICY AND LAW (2021)

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Editorial Material Orthopedics

Guest Editorial: New Medical Device Regulation in Europe: A Collaborative Effort of Stakeholders to Improve Patient Safety

Emmanuel Thienpont et al.

CLINICAL ORTHOPAEDICS AND RELATED RESEARCH (2020)

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Article Cardiac & Cardiovascular Systems

Implementing the new European Regulations on medical devices-clinical responsibilities for evidence-based practice: a report from the Regulatory Affairs Committee of the European Society of Cardiology

Alan G. Fraser et al.

EUROPEAN HEART JOURNAL (2020)

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Editorial Material Medicine, General & Internal

The 510(k) Ancestry of a Metal-on-Metal Hip Implant

Brent M. Ardaugh et al.

NEW ENGLAND JOURNAL OF MEDICINE (2013)

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The New European Medical Device Regulation: Balancing Innovation and Patient Safety

相关参考文献

Preparing healthcare, academic institutions, and notified bodies for their involvement in the innovation of medical devices under the new European regulation

Improved clinical investigation and evaluation of high-risk medical devices: the rationale and objectives of CORE-MD (Coordinating Research and Evidence for Medical Devices)

Neither protective nor harmonized: the crossborder regulation of medical devices in the EU

Guest Editorial: New Medical Device Regulation in Europe: A Collaborative Effort of Stakeholders to Improve Patient Safety

Implementing the new European Regulations on medical devices-clinical responsibilities for evidence-based practice: a report from the Regulatory Affairs Committee of the European Society of Cardiology

The 510(k) Ancestry of a Metal-on-Metal Hip Implant

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