The results in this report are from an online survey that was fielded from January 24 through February 8, 2021. It had 230 respondents, all of whom completed the survey. Key demographic variables are included below.
When rating their level of concern regarding this lack of preparedness, senior executives were 2x more likely than individual contributors to say they were "extremely concerned" about the approaching deadline.
This could signal the significance of the business risk associated with non-compliance.
Respondents identified several obstacles that are preventing them from achieving EU MDR compliance today.
Unlike our findings from our 2021 State of Medical Device report, we saw that leadership and culture weren't strong contributing factors to this lack of preparedness. Instead, respondents were more concerned about resources, processes, and clarity.
Beyond the critical action items, the survey also aimed to uncover hidden areas of challenge and friction — specifically, where different stakeholders within medical device companies disagree about key issues.
We looked at the difference between companies who said they will be ready by May 2021 and those who said they won't. Ultimately, the factors that are holding them back are similar, but the "won't be readies" saw big gaps in resources and planning necessary to hit the deadline.