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Tips for Reigniting Your MDR/IVDR Preparation
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)/In Vitro 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.
Read the full article here: Tips for Reigniting Your MDR/IVDR Preparation
