Manufacturers have less than 8 months to comply with MDR, and IVDR is around the corner
The European Union’s new Medical Device Regulation (MDR) will go into effect in May of 2020, and In Vitro Diagnostic Device Regulation (IVDR) will go into effect two years later. These new directives will bring:
- Elevated clinical requirements
- Re-classified and up-classified devices
- A changing role of notified bodies, leading to bottlenecks and delayed timelines
Collectively, these requirements will have a profound impact on the business models of medical device and diagnostic companies around the world. For manufacturers wanting to gain a competitive edge in the market, they must have the right business strategy in place prior to the implementation of MDR/IVDR.
ICON’s dedicated medical device experts can help you navigate these challenges and prepare your business for success under the rapidly approaching regulations.
To learn more, please contact us.