For the medtech industry, 2019 is going to be marked by a slew of regulatory changes, beginning with Canada’s requirement of Medical Device Single Audit Program (MDSAP), which took effect on Jan. 1. Companies that have been procrastinating are expected to be hit hard.
The deadlines for transitioning to ISO 13485:2016 and the European Union’s (EU) Medical Device Regulation (MDR) are also looming. The shifting regulatory landscape is the No. 1 development to watch for this year, according to a new white paper, “Top 5 Medical Device Industry Trends in 2019.”
Four medical device experts shared their insights and offered some advice to medtech professionals in the white paper. Two out of the top five trends they identified were related to regulations and standards.
MDSAP has replaced the Canadian Medical Devices Conformity Assessment System (CMDCAS). Class II, III and IV medical device manufacturers are now required to assess their quality management systems under MDSAP in order to sell their devices in Canada.
The program aims to harmonize standards and facilitate audits for manufacturers that sell their devices in Australia, Brazil, Canada, Japan, and the United States. Of those countries, only Canada mandates the program. The U.S. Food and Drug Administration (FDA) will accept MDSAP audit reports as a substitute to routine FDA inspections.
Health Canada, the country’s national public health authority, acknowledged that its MDSAP requirement could mean a financial burden for some medical device firms. MDSAP audits are expected to cost more than ISO audits and take longer to conduct.
“It is anticipated that some manufacturers, instead of conforming to the new MDSAP requirements, may be cancelling their medical device licenses and discontinuing the sale of their products,” the agency said. “Health care professionals should discuss with their suppliers if they have any concerns regarding the ongoing availability of their current products.” (1)
The deadline for transitioning to ISO 13485:2016 is close on the heels of Canada’s new requirement. To maintain ISO 13485 certification, device manufacturers must meet the requirements under the latest version of the standard by March 31, 2019.
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The revised standard emphasizes risk-based approach to quality management throughout the product life cycle. Companies that have not yet transitioned are likely to face a steep uphill climb. Conducting a gap analysis and then making the necessary changes to their quality systems will take months, not to mention scheduling an actual audit and training personnel on the changes. All of this requires ample time and effort.
This is also the last year for companies to transition to the European Union’s Medical Device Regulation (MDR). “European quality assurance and regulatory affairs personnel seem to be overwhelmed by preparations for the new MDR. This realization has not quite hit American companies,” said Rob Packard, a consultant specializing in 510(k) submissions and helping startup medical device companies address quality and regulatory requirements (2).
Alex Butler, manager of medical device solutions at MasterControl, agreed that the MDR will have a huge impact. He said device firms that want to stay in the European market need to invest the time and manpower to evaluate their new requirements under the new regulation. “MDR is the perfect storm and it’s coming,” he said (3).
Device experts anticipate that as part of an evolving regulatory landscape, the pace of regulatory change will increase even more. In the white paper mentioned above, faster regulatory pace is ranked No. 4 out of the top five trends to watch for.
“In fiscal year 2018, the FDA had planned to release 20 new guidances, but in reality, it issued 65! For fiscal year 2019, the FDA’s agenda includes another 27 new guidances,” said Michelle Lott, principal and founder of Lean RAQA, a regulatory and quality system solutions company. “And that’s not to mention the fast-approaching MDR implementation date in May 2020. (4)”
Christopher Devine, Ph.D., president of Devine Guidance International and a MedTech Intelligence columnist noted the urgency of new regulations. “From a regulatory standpoint, if your organization has not started migration to the EU MDR, there’s no time like the present to begin that journey. What was considered ‘optional’ under the old regulation will become mandated,” he said (5).
Regulatory agencies and notification bodies worldwide, just like regulatory teams in device firms, are struggling to address the changes, which are happening so fast.
“You can’t guarantee that your released product will not experience a hiccup in the next few years,” said Butler. He recommended educating executives on the burdens faced by regulatory teams under the new regulations.
(1) Health Product InfoWatch, published by Health Canada, Sept. 27, 2018.
(2) Rob Packard is the president of Medical Device Academy, Inc. He has 25 years of experience in the medical device, pharmaceutical and biotechnology industries. He has served in senior management positions at several medical device companies, including as president and CEO of a laparoscopic imaging company. His quality management system expertise covers all aspects of developing, training, implementing and maintaining ISO 13485 and ISO 14971 certification.
(3) Alex Butler, manager of medical device solutions at MasterControl, oversees development and continuous improvement initiatives for several MasterControl core products, including MasterControl Regulatory Excellence. He has an extensive background in medical device technology and innovation, with over eight years devoted to product development, strategic planning, quality assurance and process improvement. Prior to joining MasterControl, he served as a product development manager for Opal Orthodontics, where he was directly involved in the development, quality and compliance, risk management, registrations, and launch of several Class II medical devices.
(4) Michelle Lott is the principal and founder of Lean RAQA, a regulatory and quality system solutions company. She has nearly 20 years of health care product experience, including holding executive roles for international regulatory and quality operations. She’s currently serving on the FDA’s Device Good Manufacturing Practices Advisory Committee as an industry representative.
(5) Christopher Devine, Ph.D., president of Devine Guidance International, has 32 years of experience in quality assurance, regulatory compliance and program management. His consulting firm specializes in providing solutions for regulatory compliance, quality, supplier management and supply-chain issues facing the medical device industry. He’s a senior member of the American Society for Quality (ASQ) and a member of the Regulatory Affairs Professionals Society (RAPS) and Project Management Institute. Check out his MedTech Intelligence column
Cindy Fazzi writes about the life science industry and other regulated environments for MasterControl. She has worked as a journalist in three countries. Her two decades of experience as a news reporter, writer, and editor includes working for the Associated Press in Ohio and New York City. She has a master’s degree in journalism from Ohio State University.