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Medical Device Regulation

Ensuring safety, innovation and efficacy for patients and healthcare professionals

Implementing the new European regulations on medical devices

A report from the Regulatory Affairs Committee of the ESC was published on 2 June 2020.
The Committee considered how daily practice will change  for cardiologists, cardiac surgeons, and healthcare professionals when the new European Union law governing regulatory approval of medical devices - that entered into force in May 2017 - will take effect on 26 May 2021.

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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