The European Patients' Forum (EPF) said it welcomes last week's political agreement on the regulation of medical devices, although not without some reservations.
The May 25 agreement between the Netherlands presidency of the Council of the European Union and the European Parliament on new rules for medical devices and in vitro medical devices paves the way for stricter provisions on premarket assessment and postmarket surveillance, the EPF said. The group said it welcomes these measures, believing that a safety approach throughout a device's life cycle is key for ensuring patient safety.
In addition, the EPF praised the deal's approach toward more transparency, such as setting up a central database for information on devices and allowing access to patients and healthcare professionals. On the downside, the EPF said it regrets the uncertainty about the important question of reprocessing of devices and also the lack of details on the involvement of patients.
The EPF is calling for provisions to involve patients as experts in subgroups where their expertise can make a difference, such as patient safety, surveillance, clinical investigations, and information to patients. The group also said it would provide further analysis once the agreement is published.
