Since 2010, the ESC has been actively following the medical devices legislative process at EU level. Today, ESC experts take part in European Commission working groups supporting the implementation of the new EU regulatory framework. They have engaged in several advisory processes with EU regulators, as well as with international bodies dealing with global regulatory convergence in the field of medical devices. Read more.
The ESC is leading an EU-funded project -CORE-MD- that will look into the requirements for clinical evidence on high-risk medical devices. Recommendations will be submitted to the European Commission to be considered as a basis for developing EU guidance documents or common specifications. Read more about the CORE-MD Project.
To understand cybersecurity issues and to evaluate the implications that exist for patients and clinicians regarding data produced from remote monitoring, the ESC and EHRA have evaluated how the EU General Data Protection Regulation (GDPR) applies to remote monitoring of cardiac implanted electronic devices.
The ESC is a member of the European Medicines Agency (EMA) Healthcare Professionals’ Working Party (HCPWP), which provides a platform for the exchange of information and discussion on issues of common interest between the Agency and healthcare professionals.
Within this Working Party, the ESC has provided expertise in the areas of clinical trials, registries and big data. More specifically, with regards to clinical trials, the ESC has been selected by the Agency to represent the views of health professionals and academia in international discussions on the reform of the conduct of clinical trials.
The ESC has recently supported proposals to extend the EMA mandate. Including the transfer of the responsibility for administering the expert panels on medical devices to EMA and the creation of lists of critical medicines and medical devices to address shortages. Read more.
In December 2021, the ESC responded to the consultation for the evaluation and revision of the EU general pharmaceutical legislation, which is part of the Pharmaceutical Strategy for Europe. Among issued recommendations: the definition of unmet medical need, adaptive regulatory frameworks, medicines shortages, and the need to stimulate research and innovation in cardiovascular diseases
Health technology assessment
Health technology assessment (HTA) measures the added value of technology compared to existing ones. It provides objective information on the safety and clinical effectiveness of health interventions so that policymakers can allocate their resources judiciously.
Within the framework of the European Network for Health Technology Assessment (EUnetHTA), ESC experts contributed to the systematic HTA review of evidence on clinical effectiveness and safety of wearable cardioverter defibrillators (WCD). The ESC has also issued a statement on EU regulation on HTA, supporting the position taken by the Environment, Public Health and Food Safety Committee of the European Parliament and with other medical societies under the umbrella of BioMed Alliance.
The ESC participates in the new EUnetHTA21 consortium, providing clinical experts’ views on the draft guidance documents produced by the consortium to facilitate the implementation of HTA regulation. Medical societies like the ESC should be involved in all stages of the HTA process and could play a key role in providing high-quality evidence to support regulatory activities, expertise, and clinical practice guidelines. Medical societies should equally be involved in the process of “horizon scanning”. The ESC advocates for clear criteria and a transparent process for expert selection, as well as for the connection of individuals with collective expertise.
Well-conducted randomised clinical trials are the bedrock of safe and effective, evidence-based treatment of cardiovascular disease. However, the cost and complexity of clinical trials in CVD have risen out of all proportion. The ESC alongside other leading research organisations is fighting to improve complex and ineffective clinical trial regulation. Read more.