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Medical Device Regulation

Ensuring safety, innovation and efficacy for patients and healthcare professionals

The new EU regulatory framework on medical devices

The ESC’s engagement in the revision of the EU Directive on medical devices has contributed positively to the shaping of the new EU Regulation governing the approval of medical devices, which takes effect on 26 May 2021.

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Listen to the medical devices regulation podcast with Prof. Alan Fraser and Prof. Thomas Luescher as they explain:

  • What is the new EU Medical Devices Regulation (MDR)?
  • What do cardiologists need to know about the new MDR?
  • How was the ESC involved in shaping the new Regulation and why was this important?
  • How can cardiologists contribute to the implementation of the new MDR, in particular the assessment of new cardiovascular devices?
  • CORE MD is a new EU funded project that will review the methods for evaluating high-risk medical devices. What is the ESC's role in this project?

Read the ESC press release on the medical devices regulation implementation. 

ESC's work towards this goal

In 2020, the ESC's Regulatory Affairs Committee published a paper in the European Heart Journal on how the new regulation on medical devices will change daily practice for cardiologists, cardiac surgeons, and healthcare professionals.

Read the paper

The Working Group on e-Cardiology and the Regulatory Affairs Committee of the ESC organised a webinar on New EU regulation on medical devices. The webinar focused on the certification of medical devices and software and how health professionals can contribute to such a certification process. It also aimed to provide a better insight into the clinical testing of medical devices and to help practitioners be more informed when using or recommending possible solutions to patients.

New EU Regulations on medical devices: basic facts 

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Watch the webinar recording

Are you an expert in cardiovascular medical devices? Then the European Commission still needs YOU!

Following the new medical devices regulation (MDR), the Commission established expert panels for the evaluation of high-risk cardiovascular devices.

Your expertise could ensure that safe, effective and innovative devices reach cardiovascular patients in a timely manner. The deadline for submission of candidatures for the first cycle of appointments to the expert panels is now closed, but you can apply for a reserve list of available experts. As part of this list, you will be eligible to replace, provide advice or support the expert panels.

Review the eligibility criteria and apply to be in the reserve list.

You can download the informative flyer on the call for expression of interest for expert panels here and check the European Commission's webpage for more information.

ESC engagement

Since 2010, ESC experts have engaged with EU policymakers working on a fundamental revision of the medical device legislation to clarify and strengthen the existing legal framework dating from the 1990s.

Ongoing changes in device regulation in Europe offer exciting new opportunities for the more active participation of physicians in the shaping of regulatory landscapes.

Today, the ESC is recognised as a valid source of independent and unbiased scientific information for EU regulators. ESC experts are actively involved alongside EU regulators to ensure a smooth implementation of the new law while guaranteeing the safety and efficacy of devices used in clinical practice.

Leveraging subspecialty expertise

The new EU medical devices legislation will require the development of device-specific standards. The ESC and the European Associate of Percutaneous Cardiovascular Interventions (EAPCI) have undertaken an extensive review and meta-analysis of evidence relating to the clinical evaluation of coronary stents and bioresorbable scaffolds. These documents will be used by regulators to revise the device-specific guidance.

Scientific sessions on Medical Devices Regulations at ESC congresses