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):
- More than 35% of organizations stated that the lack of notified bodies is a significant barrier to MDR compliance. As of August 2019, only four notified bodies have been designated, with no more than 10-12 designations expected by the close of 2019.
- 66% of organizations surveyed have yet to develop a strategy to sustain compliance to MDR requirements.
- Size matters when it comes to overall preparedness. Among respondents with less than (US)$100 million in revenue, 12% said they have not started EU MDR remediation efforts — versus 7% for the largest companies. By contrast, 24% of respondents with less than $100 million in revenue said they are on target to meet the May 2020 deadline, compared with 34% for the largest device makers.
- 58% of respondents highlighted that, although they have made some progress towards the successful implementation of changes to their Quality Management Systems (QMS), they have yet to implement the changes.
- Nearly 48% of survey respondents have yet to develop a strategy for EUDAMED, an EU database collecting medical device information.
About KPMG LLP
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.
SOURCE KPMG LLP