According to a survey conducted by KPMG and the Regulatory Affairs Professionals Society (RAPS), achieving MDR compliance by the May 2020 deadline remains difficult for companies, mainly due to a lack of resources.
The survey, which closed on June 21 this year, takes into account the responses from 230 medical device organizations, 91% of which are from either Europe or North America. It concluded that there is still time to secure MDR compliance if companies work smart, but there are barriers in the way.
According to the survey, the two biggest things standing in the way of MDR compliance are a lack of available timely guidance from the European Commission and a lack of internal resources. For 36% of respondents, achieving compliance would require an estimated $5 million or more in expenditures, while more than 50% of respondents said they are planning on product launches outside of Europe.
Among the costs will be the addition of resources. Results showed that 91 of the 230 companies plan to increase headcount in an attempt to address the long-term challenges of MDR compliance, but it could have a negative impact on profit margins and may not be sustainable.
With the deadline looming large, the survey reports that 66% of respondents had not started planning for the long-term organizational ramifications of MDR compliance. Only 27% believe they will be fully compliant by the cutoff without using transitional provisions.
The lack of clarity cited by the respondents has been particularly prevalent with EUDAMED, the wide database that stands as one of the biggest changes by the EU MDR. Nearly 48% of the surveyed companies hadn’t begun developing a strategy for EUDAMED, and the survey said many are struggling to fully understand the requirements.
Companies are also concerned about post-MDR sustainability, as 66% in the survey have yet to develop a plan for what comes next, due to uncertainty about timelines with compliance.
The final suggestion from KPMG/RAPS was to “position your EU MDR effort with leadership as more than just a regulatory obligation.” The surveyors believe companies should reframe the initiatives as an opportunity to restructure organizations for long-term value after compliance is achieved.
