The European Medical Device Regulation 2017/745 (MDR) is published on May 5th, 2017 in order to replace the current Medical Device Directive 93/42/EEC; meaning that from 2020 onwards only MDR will apply and before that time both the MDR and MDD apply. Medical device vigilance (MDV) is a key element that is significantly reinforced in the new MDR. The European database on medical devices (Eudamed) will be revised to include vigilance data. These changes make the procedures similar to the Eudravigilance database and the pharmaco-vigilance (PV) process.
The MDV requirements affect the entire medical device (MD) industry with products in the EU. They will need to adjust and upgrade their quality management systems, and implement the required
Because of similarities, it might be tempting to follow PV procedures and systems in order to meet MDV requirements. However, this might not be the right approach because there are distinct differences. In this presentation, we will look at similarities and differences: what can we share and where do we need to pay attention to, in order to ensure compliance with the new regulations.
Recently Xendo colleague Jan Bart Hak presented on this at PhV Day 2017 and below you can find the slide