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Paving the way for innovation in medical devices

ESC Congress News 2018 - Munich, Germany

In just two years’ time, significant changes in European regulations for new medical technologies will come into force.

Device Therapy
Health Policy

fraser-alan-2018-congress-news.jpg“With over 500,000 medical devices available in Europe, including many high-risk implantable devices that are used in our daily practice, cardiovascular medicine will be impacted enormously,” says Professor Alan Fraser (University Hospital of Wales, Cardiff, UK), Chair of the ESC EU Regulatory Affairs Committee on Medical Devices, following yesterday’s session on innovation in medical devices.

“EU legislation determines the types of medical devices doctors can access and this impacts clinical practice.”

“Medical devices are essential to modern medicine and we couldn’t treat our patients without them,” says Prof. Fraser. “The ESC has been working with EU policymakers since 2010 to clarify and strengthen the existing legal framework which determines what devices are made available on the EU market,1” he says. “Today we are pleased to see that the new legislation addresses many of the concerns we raised.2

“For the first time, safety and clinical performance data for each new device obtaining CE mark will be publicly available.”

Passed in May 2017, the law moves beyond the previous requirements to establish that a medical device is safe and that it performs the task it was designed for. “From 2020, every device used by cardiologists in the diagnosis and treatment of patients will be subject to greater scrutiny and reinforced requirements for clinical evidence,” says Prof. Fraser. “In addition, high-risk devices will now be required to show a positive impact on clinical outcomes.” He thinks these new provisions are extremely good news for clinicians and for patients. “The legislative changes will foster high standards for medical devices. Clinicians will feel more confident in their clinical decisions and choice of device and patient safety will be improved.”

“This new legislation provides doctors with an exciting opportunity to become more actively involved in shaping the regulatory landscape.”

The new regulations will also require greater involvement of healthcare professionals. For example, expert panels and expert laboratories will be designated to provide scientific, technical and clinical advice. Individuals will also have the opportunity to answer calls for volunteers to participate in ad hoc Expert Working Groups. Prof. Fraser recognises that this is unfamiliar territory for many doctors, which is why he encourages delegates to attend today’s session, where these general elements will be explained and concrete examples will be provided, with reference to electrophysiology and software as a medical device. ESC members wishing to know more may also consult the ESC website and/or contact the ESC Advocacy Team.

  1. Fraser AG, et al. Eur Heart J 2011;32:1673–1686.
  2. Fraser AG, et al. Lancet 2018;392:521–530.


Click here to read other scientific highlights in the ESC Congress news.

Notes to editor

About the European Society of Cardiology

The European Society of Cardiology brings together healthcare professionals from more than 150 countries, working to advance cardiovascular medicine and help people lead longer, healthier lives.

About ESC Congress 2018

ESC Congress is the world’s largest and most influential cardiovascular event contributing to global awareness of the latest clinical trials and breakthrough discoveries. ESC Congress 2018 takes place 25 to 29 August at the Messe München in Munich, Germany. Explore the scientific programme