The COVID-19 pandemic clearly dropped a wrench in the gears of many industries as well as the normal routines of people across the globe. Through most of 2020, organizations scrambled to revise business strategies and processes to remain operational--and six feet apart--during the unique circumstances. It was a pivotal year for medical device companies that were busily preparing for the Medical Device Regulation (MDR)/InVitro Device Regulation (IVDR), which was fast approaching. Then, in an 11th-hour decision, the industry received a welcome respite when the deadline was pushed out to May 26, 2021.
Medical device manufacturers no doubt enjoyed having a breather to focus on more pressing issues. Stalled clinical trials, disrupted supply chains, and halted manufacturing lines have been common scenarios due to the pandemic. Nevertheless, several months of the moratorium have passed, and now, the task of preparing for the European Union's (EU) regulatory upgrade is back on their plates.
Restarting an already arduous project mid-stream can be daunting. Still, the clock is ticking again, and it's time to dust off transition plans and get moving. To get the MDR/IVDR preparation ball rolling again, following are four processes to help refocus on achieving compliance with the updated MDR/ IVDR Regulations.
What has changed? What changes are considered significant?
Open channels of communication with your peers and colleagues--they are your allies. Over the course of the delay, changes most likely occurred in some aspects of your product or organization. In your conversations, identify what has changed and determine what the significant changes are that need to be readdressed in the plan. The more you can create some dialog around what significant change means, the better the whole organization will be at making the changes together.
Some questions to bring up might include:
* Are the business and product strategies still applicable, or have they changed in a way that will impact compliance with MDR/IVDR?
* Are the distributors and economic operators you were planning to work with in Europe still available? What is their transition status, and what are their plans for the future?
* There are emergency use authorization (EUA) plans in the U.S. that a lot of medtech companies pivoted to support. Will those be launched in Europe as well?
For instance, some changes...