July 17th 2020: This document has been updated to reflect regulatory changes in response to COVID-19. As this is a rapidly evolving situation, additional regulatory changes may occur.
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.
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:
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.