Cardiologists call for a single European system to oversee medical devicesBMJ 2011; 342 doi: https://doi.org/10.1136/bmj.d3144 (Published 19 May 2011) Cite this as: BMJ 2011;342:d3144
- Jacqui Wise
The European Society of Cardiology has called for a single coordinated European system to oversee the evaluation and approval of medical devices. It says this could be organised as a division of the European Medicines Agency or as an entirely new body.
The society believes that the regulatory system in Europe has not kept pace with technological advances and the changing patterns of medical practice. It says that after several well publicised failures of cardiovascular devices causing clinical problems, concerns have arisen about the adequacy of current standards of evaluation before approval. New European Union legislation is being drafted during 2011, but medical experts say they have had little involvement in the process.
The organisation presents its main recommendations in a …