Updated: Mar 1, 2019
The implementation of the new European Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) has reached a critical momentum.
With only 20 months left in the transition period for MDR, medical device manufacturers that want to place medical devices on the EU market after 26 May 2020 are working diligently to implement the new regulatory requirements.
When it comes to budgeting and planning for additional regulatory resources, many manufacturers are still in gap analysis mode. The five hottest topics to meet compliance with MDR are:
- Clinical investigation and evaluation
- New roles and responsibilities for “economic operators”
- Postmarket surveillance and vigilance, and market surveillance
- Risk management and usability engineering/ design input
- Overhaul of labeling and technical documentation