Under new rules to market medical devices in the European Union (EU), only 27% of respondents said they will be fully compliant with the regulations set to go into effect May 26, a survey from the Regulatory Affairs Professionals Society (RAPS) and KPMG LLP, the U.S. tax, audit and advisory firm, found.
However, 46% of the companies participating in the survey will leverage the EU Medical Device Regulation’s transitional provisions to continue to sell their current medical devices in the EU Markets through 2024 while working on their compliance programs, placing additional work on organizations to recertify products and manage inventory.
EU MDR sets more stringent rules and data collection programs to improve patient safety by ensuring unsafe or non-compliant medical devices are kept off the market. The survey of 230 of the industry’s regulatory affairs professionals also revealed pervasive concern over a shortage of notified bodies designated as medical device inspection authorities. In the EU, notified bodies must assess medical products before they can be marketed.
“EU MDR requires medical device manufacturers to address rising expectations that come with the new law,” said Rajesh Misra, an advisory principal in KPMG’s healthcare & life sciences practice. “Without adequate planning and budgeting, EU MDR compliance efforts could lead to strained resourcing, employee resistance, insufficient training, and communication failures across the organization – causing barriers to get EU MDR compliant products to the market. Companies should also start considering the operating model changes to support EU MDR sustainability.”
“The low number of notified bodies designated so far is making medical device companies particularly apprehensive because they perform a necessary part of the European device approval process,” said RAPS Executive Director Paul Brooks. “If there are too few notified bodies or their capacity to assess devices under EU MDR is inadequate to meet the demand, it will create bottlenecks that could result in product shortages, including for critically important and high-risk devices patients depend on.”
Additional findings from the KPMG-RAPS EU MDR survey include (click here to see the full report):
KPMG LLP is the independent U.S. member firm of KPMG International Cooperative (“KPMG International”). KPMG International’s independent member firms have 207,000 professionals in 153 countries and territories. Learn more at www.kpmg.com/us.
The Regulatory Affairs Professionals Society (RAPS) is the largest global organization of, and for, those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products. Founded in 1976, RAPS helped establish the regulatory profession and continues to actively support – and lead – the profession as a neutral, non-lobbying, nonprofit organization. RAPS offers education and training, professional standards, publications, research, knowledge sharing, networking, career development opportunities and other valuable resources – including its Regulatory Affairs Certification (RAC), the only post-academic professional credential to recognize regulatory excellence. RAPS is headquartered in suburban Washington, D.C., with chapters and affiliates worldwide.