IVDR: How to Prepare for New Regulations and Move Successfully to CE Mark
The new Vitro Diagnostic Regulation legislation comes into force on May 26, 2022. Diagnostic device manufacturers are working hard to ensure design, manufacturing, and post-market surveillance and vigilance of their products comply with the new regulations. As the clock ticks, few manufacturers are fully prepared: according to a survey conducted by MedTech Summit and NSF in early 2021, only 15% of respondent organizations were fully prepared to meet the IVDR deadline. One of the main reasons for the delay was COVID-19. Almost all (95%) of respondents said the pandemic had impacted their IVDR implementation. While the European Commission recently proposed to adapt the full IVDR mandatory application dates depending on the class of medical device, organizations that are not already working with a Notified Body on CE mark submission may have a tough few years ahead. Download our whitepaper to find out more from Cerba Research.