The Race to EU MDR Compliance Continues

Sep 25, 2019

Despite progress over the past year, medical device companies are still facing many questions, according to annual KPMG/RAPS survey.

Posted by KPMG LLP

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)

  • 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.

Download Attachment

See all Member News