Since 2010 HOPE is a member of the European Commission Expert Group on Medical Devices (MDEG). The group is composed of industry and other stakeholders’ representatives in the area of medical devices and discusses issues related with the implementation of the Medical Devices Directive.
In 2012, the European Commission published two proposals of revised Regulations on medical devices and in-vitro diagnostic medical devices. These proposals came after the French breast implants scandal and aimed at reinforcing patient safety by strengthening supervision regarding the safety of medical devices on the market and improve information to patients.
HOPE closely monitored the legislative process in the European Institutions and advocated that, when done in a safe way, the re-use of medical devices is a way to reduce costs and contribute to the protection of the environment. Reprocessing of medical devices results in the reduction of procurement costs, better use of cleaning and sterilisation equipment and in the reduction of inventory, waste and overall consumption of raw materials and primary energy.
The European Parliament voted on the draft texts in April 2014. To be adopted, the legislations still need to be approved the Council of the EU.