Medical devices include a wide range of products, from contact lenses and bandages to pace-makers. There are more than 500,000 different types of devices on the market that are used in the diagnosis, prevention, monitoring and treatment of diseases and in improving the quality of life of those with disabilities. While there are rules on medical devices, the scandal with defective breast implants in 2011 raised a number of questions about ethics and safety, about oversight and how the rules could be improved.

As part of the drive to harmonise rules and procedures, impose stricter requirements for the assessment of medical devices and improve their traceability, the European Commission, in September 2012, adopted two legislative proposals on medical devices and in vitro diagnostic medical devices which will, once adopted by the European Parliament and by the Council, replace the existing directives. The Commission and the Member States have also carried out joint actions to improve control over medical devices on the basis of existing legislation.

This briefing saw European Commissioner for Consumer Policy Neven Mimica addressing important questions regarding the control of medical devices, advancement, and the benefits of the new legislation for EU citizens, consumers and industry. Outlining the main elements of the new proposals Mimica explained the current state of play in the negotiations in the Council and Parliament as well as what to be expected for the future.