European Parliament votes for improvements in EU Medical Devices Directive
Eucomed has voiced their approval on the majority of measures recently voted on in a plenary session by the European Parliament to improve the European Union Medical Devices Directive, including increased transparency and traceability of medical devices, better stakeholder involvement and increased unannounced visits to sites.
“The Parliament has voted for many improvements that will effectively improve patient safety. We believe that this paves the way for further needed improvements to be discussed with the Council,” Serge Bernasconi, chief executive officer of Eucomed, stated in a Eucomed press release. “We congratulate the Parliament in finding more clarity and positive approaches in important areas supporting safety of patients and innovation for patients in what has been a very complex and highly technical dossier. We are looking forward to seeing continued evolution on a future strengthened EU framework for medical devices.”
Other additions to the EU Medical Devices Directive voted on by the European Parliament are a change in how medical devices are approved. The change in “approach and direction [is] to a more manageable process without compromising the shared goal of improving patient safety,” according to the release.
Although Eucomed found the majority of measures voted on were positive, they expressed concerns about the decision to consider multiple approaches for reprocessing single-use medical devices.
“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,” according to the release. “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.”