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Responsibilities and roles of Notified Bodies according to the EU Medical Device Regulation (2017/745)

New Medical Device Regulation. ESC podcast with Prof Alan Fraser and Prof. Thomas Lüscher

New Medical Device Regulations Take Effect in Europe. 2 June 2021, tctMD.

Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices.

Regulation (EU) 2017/745 on Medical Devices.

Fraser AG, et al.The need for transparency of clinical evidence for medical devices in Europe. Lancet. 13 July 2018.

IMDRF.Clinical Evaluation. 10 October 2019.

Reckers-Droog V, et al. Challenges with coverage with evidence development schemes for medical devices: a systematic review. Health Policy Technol. June 2020.

Fraser AG, et al. 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. EHJ. 14 July 2020

CORE-MD project handbook

Recommendations

Regulating drugs, medical devices and diagnostic tests in the European Union –lessons from the COVID-19 pandemic?

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This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 965246.

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