An industry survey conducted by KPMG and the Regulatory Affairs Professionals Society (RAPS) found little familiarity with the European Union’s new Medical Device Regulation and its requirements that take full effect in May 2020.
When asked if they were confident their companies would be able to meet the regulatory deadline, 45% of North American and 29% of European respondents said “not very.”
Specifically, concerns centered on clinical data collection and new rules covering postmarket surveillance and tracking of cleared medical devices.
“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 and life sciences practice, said in a statement.
According to the survey (PDF), 78% of medical device company respondents do not have a sufficient understanding of the EU MDR, while 58% said they had no strategy in place to fix gaps in their clinical data or collection processes. Additionally, 39% of organizations have not yet identified a Person Responsible for Regulatory Compliance, a new role required by the MDR.
The EU updated its regulations in 2017 covering product evaluation, with more stringent procedures aimed at ensuring the rejection of unsafe or noncompliant equipment.
KPMG and RAPS suggest that device manufacturers evaluate the sturdiness of their products’ clinical evidence and address changes that need to be made in the recertification process for existing products. They also recommended that companies build cross-functional teams from quality assurance, supply-chain management and regulatory compliance to tackle the issues.
“Preparing for the EU MDR is a major challenge for medical device companies in the European market,” said RAPS Executive Director Paul Brooks. “And while there is still a great deal of uncertainty surrounding regulators’ interpretations and expectations, those who are proactive in developing regulatory strategies and contingency plans will very likely find themselves in the strongest position when the 2020 deadline arrives.”
KPMG and RAPS’ survey gathered 220 responses in June from regulatory affairs or quality-assurance professionals, with 36% from companies with less than $10 million in annual revenue. Another 36% of respondents came from organizations with annual revenues between $10 million and $999 million, while the remaining 28% were from those with more than $1 billion.