The European Society of Cardiology has called for a co-ordinated European system to oversee the approval of medical devices. The ESC is concerned about the adequacy of current standards of evaluation after several failures of cardiovascular devices. They believe the European regulatory system needs to be updated.
Speaking today Liam Moloney, medical Solicitor said, “There is currently no single common European agency for assessing medical devices, and regulation is the responsibility of the 27 member states of the EU. Under the current system a medical device company is free to approach any notified body in Europe for approval. In Europe an estimated 200,000 different types of medical devices are produced by more than 11,000 companies. The ESC has called for a single co-ordinated European system to oversee the approval of medical devices. The society wants product standards to be developed for each category of medical device in both medium and high risk categories. The ESC wants companies that manufacture these to be responsible for independently monitored clinical studies of their devices including randomised controlled trials where needed”.
If you have suffered an injury from a medical device you may be entitled to recover compensation. Please call Liam Moloney, Solicitor, today at 045 898000 or simply log onto our website www.moloneysolicitors.ie for more information regarding your rights.
