top takeaways

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Only 18% are ready for eu mdr today

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Obstacles are related to knowledge, clarity, and resources


There are many points of friction hiding in plain sight


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.

Only 18% are ready today

With just a few months left until the EU MDR deadline, only 18% of respondents report being ready for the regulatory changes today. The majority of respondents said they should be ready by the deadline, but a whopping 30% will not be fully prepared by May.


Concern is highest among executives

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. 


The Obstacles We're Facing

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.

Hidden points of friction



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.


70% have not developed an operational plan for business continuity
62% have not determined a reclassification plan
51% haven't documented a strategy to remediate gaps in clinical data
38% said they are currently unable to incorporate PMS data into their technical documentation

What sets aside those who are prepared?

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.


(cover) 2021 EU MDR report


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