Four-fifths of regulatory and quality leaders at medical device companies lack understanding of the incoming European Union Medical Device Regulation, according to a survey of more than 200 professionals conducted by professional services firm KPMG and Regulatory Affairs Professionals Society (RAPS).
The difficulty of understanding the requirements emerged as the biggest perceived barrier to compliance, coming in ahead of the much-discussed risks posed by the potential shortage of notified bodies.
Faced with these challenges, 45% of North American companies and 29% of their European counterparts are not confident they will be able to meet the impending deadlines.
New medical device regulations are due to come into force in Europe in 2020. The deadline has been known since the regulation was passed in 2017. However, there are signs that some companies will struggle to read, understand and act on the 123 articles and 17 annexes set out in the regulation by the time it goes live next year.
The latest evidence that the timeline is too tight for some companies comes from the survey conducted by KPMG and RAPS in June. The survey gathered the views of 220 regulatory and quality professionals who work at small to large medtech companies, mostly in the EU and North America.
Two-fifths of respondents said their organization is either yet to read the regulation or has only a basic level of understanding of its implications. A further 37% of respondents said their organization has a "moderate" understanding of the regulations.
"Medical device makers need to understand that migration to EU MDR will not happen overnight, but a comprehensive plan that brings R&D, regulatory, quality, operations and medical affairs disciplines together will position an organization on the right path," Rajesh Misra, advisory principal in KPMG's healthcare & life sciences practice, said in a statement.
The widespread lack of understanding and, by extension, preparedness has implications for the likelihood that organizations will be compliant with the regulations when they come into force. Just 7% of North American companies and 16% of European businesses are extremely confident that they will meet the deadlines. A larger proportion of companies are not very confident.
In light of the findings, KPMG thinks companies should build cross-functional teams and task staff members with reading different parts of the sprawling regulatory documents. These people should then present their findings in a way that resonates with other divisions of the company, particularly the C-suite.