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With a 2020 deadline looming for the European Union’s Medical Device Regulation (MDR), medical device makers “lack understanding of the new rules that govern the ability to sell products in one of the world’s largest markets,” according to a survey by KPMG and the Regulatory Affairs Pro­fessionals Society (RAPS).

The European Union updated regulations in 2017 governing product evaluation on medical devices and their accessories. The goal was to improve patient safety with more stringent procedures in order to ensure that unsafe or noncompliant equipment stays off the market. In addition, the new rules, which go into effect May 2020, address post-market surveillance, such as data gathering for medical devices on the market.

But the KPMG/RAPS survey, titled “The Race to EU MDR Compliance,” revealed some troubling findings:

  • 78 percent of medical device companies do not have a sufficient understanding of EU MDR.
  • 58 percent of all respondents said they had no strategy in place to remediate gaps in their clinical data or processes for collecting data.
  • When asked about the confidence about being able to meet the regulatory deadline, 45 percent of North American and ­29 percent of European respondents were “not very confident.”

KPMG and RAPS suggest in the report that medical device makers should evaluate their products’ clinical evidence right away to see whether there are any gaps and develop a remediation plan; address changes that need to be made in the recertification process for existing products; and build cross-­functional teams from quality assurance, supply chain management and regulatory compliance.

“Preparing for the EU MDR is a major challenge for medical device companies in the European market,” says 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.”

The survey, conducted in June 2018, analyzed 220 survey responses of regulatory affairs or quality assurance professionals from a variety of medical device organizations. Just more than a third (36 percent) came from companies with less than $10 million in annual revenue. Another 36 percent of respondents came from organizations with annual revenue between $10 million and $999 million. The remaining 28 percent of respondents were from organizations with more than $1 billion in annual revenue. Geographic distribution of the respondents is as follows: 45 percent, North America; 45 percent, Europe; 6 percent, Asia; 2 percent, Oceania; and 1 percent, Middle East (figures account for rounding).

Sherrie Trigg

Editor and Director of Medical Content

To download a copy of the study, go to https://institutes.kpmg.us/ content/dam/institutes/en/healthcare-life-sciences/pdfs/2018/the-race-to-eu-mdr-compliance.pdf.