Brussels, 22 October 2013 - Eucomed, the European medical technology industry association, welcomes the majority of measures adopted today in a plenary vote by the European Parliament on the revision of the EU Medical Devices Directive (MDD). Members of the European Parliament (MEPs) have voted for much-needed measures to improve Europe’s notified body system, increase the transparency and traceability of medical devices, introduce unannounced site visits and provide for better stakeholder involvement. On the approval system for medical devices, Eucomed positively notes that Parliament has shifted the approach and direction to a more manageable process without compromising the shared goal of improving patient safety. On the reprocessing of single-use medical devices, by adopting a variety of different elements, some newly introduced at Plenary, the approach taken still leaves significant concerns for patient safety as well as legal inconsistencies. For example, reprocessors are not subject to any conformity assessment. This seems at odds with the European Parliament’s stated desire to install a high level of patient safety throughout Europe. All in all, Eucomed believes that this vote will send a strong signal towards Council that Parliament is interested in finding a balanced, implementable solution that guarantees both better patient safety and a vibrant and innovative MedTech sector.