With less than one year until May 2020, the Medical Device industry is still grappling with achieving MDR compliance. Organizations now have a better understanding of the legislation, enabling them to assess their progress toward compliance with the new requirements. However, there are new questions—many of which remain challenging to answer despite the looming May 26, 2020 Date of Application.
To help organizations get a pulse on where the industry stands and their progress relative to competitors, KPMG and RAPS surveyed more than 230 industry leaders again this year.
This paper presents complete survey results and guidance on next steps. Some significant highlights from our research include:
-Only 28% of respondents with revenue of more than $1 billion plan to declare full MDR compliance by May 2020.
– 57% of respondents are still in the process of renewing their MDD certificates so they can leverage the much-needed transitional provisions (noted in Article 120 of the EU MDR).
Read our findings below, and email us to request the full survey results.