Under new rules to market medical devices in the European Union (EU), only 27 percent of respondents said they will be fully compliant with the regulations set to go into effect May 26, 2020, a survey from the Regulatory Affairs Professionals Society (RAPS) and KPMG LLP, the U.S. tax, audit and advisory firm, found. The new rules repeal the existing Medical Devices Directive and Active Implantable Medical Device Directive, both of which came into force in May 2017.
The survey found that 46 percent of the companies participating in the survey plan to 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.
According to RAPS, the EU MDR sets more stringent rules and data collection programs to improve patient safety by ensuring that unsafe or noncompliant 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,” says Rajesh Misra, an advisory principal in KPMG’s healthcare and 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.”
Additional findings from the survey include:
More than 35 percent 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 percent 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 $100 million in revenue, 12 percent said they have not started EU MDR remediation efforts versus 7 percent for the largest companies. By contrast, 24 percent of respondents with less than $100 million in revenue said they are on target to meet the May 2020 deadline, compared with 34 percent for the largest device makers.
58 percent of respondents highlighted that, although they have made some progress toward the successful implementation of changes to their quality management systems, they have yet to implement the changes.
Nearly 48 percent have yet to develop a strategy for EUDAMED, an EU database collecting medical device information.
Editor and Director of Medical Content
To read the full survey results, go here .