Brussels, 26 May 2021: The EU Regulation on Medical Devices (EU 2017 /745) (1) enters into application today, providing a system that will benefit patients enormously.
The European Society of Cardiology (ESC) welcomes this new regulatory framework that will increase patient safety and clinical evidence for the hundreds of high-risk medical devices used to treat cardiovascular patients. However, the ESC has serious concerns over the lack of available resources to put in place such an ambitious piece of legislation.
Since 2010, the ESC has greatly contributed to the policy debate on medical devices, bringing the expertise of frontline clinicians to EU decision-makers to improve the safety of patients and the performance of devices, while encouraging innovation. The new Regulation will bring many improvements to the medical devices system that the ESC has advocated, such as: greater involvement of clinicians, scientists, and engineers in the scrutiny of evidence for medical device certifications; stronger safety requirements for high-risk medical devices and post-market surveillance, and access to safety and clinical performance data for new devices.
However, there are still gaps that could jeopardise successful implementation of the Regulation. The number of designated notified bodies is insufficient to face the certification requests made by manufacturers, the date of the full implementation of the EUDAMED data base is still unclear and in particular the regime applicable for high-risk devices needs to be further developed. There are some positive initiatives to palliate this situation such as CORE-MD (2), a Horizon 2020 project coordinated by the ESC, that will review the methods for evaluating high-risk medical devices, but much more needs to be done to ensure progress and a fully functional system.
Professor Alan Fraser, Past Chair of the ESC Regulatory Affairs Committee said: “Limited capacity and manpower at European Commission level threaten the effective implementation of the Regulation (3). As a minimum the recommendation in the Impact Assessment for the Regulation should be followed. This document clearly states that fifty full time employees at EU level would be needed to fulfil the tasks envisaged by the Regulation. Unfortunately, there are not even a quarter of this number of staff currently dedicated to the Medical Devices Regulation in DG SANTE (4).”
Professor Piotr Szymanski, Chair of the ESC Regulatory Affairs Committee added: “The European Medicines Agency has approximately 900 staff (5) dedicated to the regulation of pharmaceutical products but the number of staff in the European Commission responsible for the Medical Devices Regulation is only 1% of this number. This clear imbalance is worrying and unsustainable. Investment needs to be increased urgently to boost the capacity and manpower of the European Commission. The successful implementation of the Regulation is a fundamental priority for patients and healthcare professionals requiring access to safe, innovative and effective technologies.”