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.
A recent report surveying representatives from the medical device industry across the globe said that more than 75% claimed only a basic understanding of how to prepare for MDR compliance. Furthermore, running full clinical trials, resubmission, and setting up post-market surveillance will be an enormous challenge.
With less than 9 months, 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 2020. Here’s a quick preview of the 6 steps:
Step 1: Which devices will stay or go?
Step 2: Do you have the right clinical data?
Step 3: Are you talking to the right notified bodies?
Step 4: Confirm timeline with your notified body
Step 5: Apply on time
Step 6: Apply for a 4-year extension—But be careful (Optional)
Download your copy of the White Paper by filling out the form below.