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, 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 the area of pharmaceuticals, the ESC has contributed views for the preparation of the EU pharmaceutical strategy, calling on the adoption of measures to tackle the increasing burden of cardiovascular disease.
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.
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.