Survey: medical device companies insufficiently prepared for the new MDR

The survey, conducted by Regulatory Affairs Professional Society (RAPS) and KPMG in June 2018 shows how insufficiently prepared are the medical device companies for the new Medical Device Regulation (MDR).

Many of the queried 220 medical device companies show lack of long-term plans for compliance to the MDR. Only 21% of respondents reported having a deep understanding and a strategy for dealing with MDR’s impact; 41% of companies indicated little to no understanding of the Regulation. Nearly 80% of respondents currently lack sufficient understanding of the MDR, according to survey results.

Using information from respondents’ replies, survey autors listed several high-level challenges to MDR compliance, as well as recommendations to address these issues within the MDR’s 2020 compliance timeframe.

For the survey please go to RAPS-KPMG-survey.


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