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Medical Device Regulation

Ensuring safety, innovation and efficacy for patients and healthcare professionals

Call for experts in medical devices

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

In just eight months, the new medical devices regulation (MDR) will be implemented. This will have enormous implications for the cardiovascular community and for patients across Europe.

Your expertise could contribute to ESC advocacy endeavours to ensure that safe, effective and innovative devices reach cardiovascular patients in a timely manner.

Become a member of the new European Commission expert panels to evaluate high risk CV devices.

Review the eligibility criteria and apply by Sunday 24 November.

Apply to join expert panel

You can download the informative flyer here and check the European Commission's webpage for more information.

ESC Regulatory Engagement

europe.pngSince 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.

The new EU legislation on medical devices approved in 2017 will have important implications for medical professions: particularly because of the foreseen increased involvement of scientific experts in the regulatory process. 

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.

On 17 June 2019 in Brussels the BioMed Alliance, together with the European Society of Cardiology (ESC) and the European Federation of National Associations of Orthopaedics and Traumatology (EFORT), are organising a Joint Workshop on Medical Device Registries.

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On 21 March 2018 in Brussels, ESC organised an unprecedented meeting involving leading scientists from ESC specialty groups and twenty other medical associations to discuss the impact of the European regulatory landscape on clinical practice with EU and national regulators.

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Leveraging Subspecialty Expertise

stent.pngThe new EU medical devices legislation will require the development of device-specific standards applicable to medical devices. 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.

Health technology assessment (HTA) measures the added value of a technology compared to existing ones. It provides objective information on the safety and clinical effectiveness of health interventions, so that policymakers may allocate their resources judiciously. HTA is also crucial for healthcare professionals because it encourages evidence-based policies. Within the framework of the European Network for Health Technology Assessment (EUnetHTA), ESC experts contributed to the systematic health technology assessment (HTA) review of evidence on clinical effectiveness and safety of wearable cardioverter defibrillators (WCD).

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