The impact of the Medical Device Regulation on the medical device industry is substantial as the regulations focus on the complete product lifecycle from device development to post-market surveillance. More importantly, the MDR aims to improve patient safety by making it easier to identify any issues with medical devices in the market. Although the MDR is a step in the right direction, it is going to be immensely challenging for smaller companies to comply with it. Furthermore, running full clinical trials, resubmission, and setting up post-market surveillance will be an enormous challenge. Despite delays due to the pandemic, the time to act is now.
This white paper provides 6 practical steps that every medical device company needs to take to ensure MDR compliance by May 2021.
Here’s a quick preview of the 6 steps:
- Find out which devices will stay or go.
- Check if you have the right clinical data.
- Check if you are talking to the right notified bodies.
- Confirm timeline with your notified body.
- Apply on time.
- Apply for a 4-year extension—But be careful (Optional)