The race to EU MDR compliance

In June 2018, KPMG and the Regulatory Affairs Professionals Society (RAPS) conducted a comprehensive survey of more than 200 regulatory and quality leaders at major medical device companies to evaluate where individual organizations stand on the road to MDR compliance. The results yielded several key, and sometimes surprising, insights.

This paper looks at several key areas on the road to MDR compliance and:

• Highlights where companies of different sizes and types fall when it comes to the issues detailed in this paper by assessing the challenges they face.
• Recommends immediate actions by diving into what to do now.
• Provides insight into how these changes are likely to play out in the long run.