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COVID-19 and Cardiology

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New EU regulation on medical devices: basic facts

ESC webinar on general cardiology organised by the Working Group on e-Cardiology and the Regulatory Affairs Committee of the ESC.

17/04/2020 18:00 17/04/2020 19:00 Europe/Paris New EU regulation on medical devices: basic facts

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European Society of Cardiology DD/MM/YYYY
European Society of Cardiology
European Society of Cardiology
Interventional Cardiology and Cardiovascular Surgery
E-Cardiology, Digital Health, Public Health and Economics, Research Methodology
Risk Factors and Prevention
Arrhythmias and Device Therapy
Heart Failure

Focus on

Learning objectives

After watching the webinar, participants will be able to:

  • Know how the certification of medical devices works in EU, how it differentiates from the drug approval, and understand main differences with USA-FDA system
  • Know the main changes that are introduced by the new EU Medical Device Regulation
  • Know how healthcare professionals can contribute to the medical device certification process based on their expertise, and on the post-market surveillance activity, in particular for implanted devices
  • Know how the certification process will impact currently available medical devices and software (including apps, risk factor calculators, artificial intelligence, computational models)
  • Acquire a better insight on the level of clinical testing of the medical devices, and then to be more informed in using or recommending possible solutions to patients

Watch the webinar recording



fraser-alan-2016.jpgProfessor Alan Fraser, FESC
Wales Heart Research Institute
University Hospital Of Wales
Cardiff, UK

caiani_enrico gianluca-2016.jpgProfessor Enrico Caiani, FESC
Politecnico Di Milano
Electronics, Information and Bioengineering
Milan, Italy


piscoi-paul-2020.jpgDoctor Paul Piscoi
Scientific Policy Officer
European Commission
Health Technology Unit
Directorate General for Health (DG SANTE)
Brussels, Belgium




Professor Robert Byrne, FESC
Dublin Cardiovascular Research Institute
Mater Private Hospital
Dublin, Ireland



Session information

This webinar is designed for all practicing cardiologists working in the field of

  • Interventional cardiology
  • Arrythmias, EP specialist
  • Prevention
  • Heat failure
  • e-Cardiology

During the webinar, you will be encouraged to send your questions by chat and interact with our key opinion leaders who will provide live feedback.

Technical settings

The webinar is available on PC and tablets. The use of a smartphone is not recommended.

To answer the MCQs during the live, you must allow pop-up windows.

A high-speed Internet connection is required (minimum 2 Mbps).