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
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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