| Short Description |
The upcoming Regulation on Medical Devices will change the landscape for the development of medical devices in Europe but also in the current legislative framework there is room for improvement in mitigating risks in the clinical development and life cycle management of medical devices. This multi-stakeholder workshop of the newly formed joint EFGCP – MedTech Europe Medical Technology Working Party will offer the floor for an exchange of views, opinions and proposed solutions on ethical, safety and quality topics of particular complexity and concern in the current and upcoming medical device legislation amongst all stakeholders. For the first time, patient representatives, healthcare providers, ethicists, competent authorities, industry and politicians will be encouraged to present and discuss together the needs, options and opportunities for mitigating risks in the development and full life cycle of medical devices in a neutral multi-stakeholder forum. In this first workshop we will discuss the similarities and differences between the development of medicines and medical devices, areas of mutual learning about suitable procedures in clinical trials and overall development concepts in the interest of the patient, identify the key ethical and quality issues and particular practical questions to be worked out in more detail in subsequent workshops. |
