Medical Device Makers Grapple with European Regulatory Deadline, Says KPMG
With a 2020 deadline looming for the European Union’s Medical Device Regulation (MDR), regulatory affairs and quality leaders at 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, with the aim of improving patient safety with more stringent procedures for ensuring unsafe or non-compliant equipment stays off the market. Additionally, the new rules, which fully go into effect May 2020, address post-market surveillance, such as data gathering for medical devices on the market.
The KPMG LLP and Regulatory Affairs Professionals Society (RAPS) survey, titled “The Race to EU MDR Compliance,” found:
- 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.”
“Medical device makers need to understand that migration to EU MDR will not happen overnight, but a comprehensive plan that brings R&D, regulatory, quality, operations and medical affairs disciplines together will position an organization on the right path,” said Rajesh Misra, advisory principal in KPMG’s Healthcare & Life Sciences Practice.
KPMG and RAPS suggest in the report that medical device makers should evaluate their products’ clinical evidence right away to see if 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,” said 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 Race to EU MDR Compliance” is an analysis of 220 survey responses in June 2018 of regulatory affairs or quality assurance professionals from a variety of medical device organizations. Just more than a third (36%) 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).
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 the professional 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 Regulatory Affairs Certification (RAC), the only post-academic professional credential to recognize regulatory excellence. RAPS is headquartered in suburban Washington, DC, with chapters and affiliates worldwide. www.RAPS.org