Dawn A. Lissy, President & Founder, Empirical08.14.19
I’m generally an optimistic person. My outgoing voicemail greeting encourages every caller to “keep smiling!” My wardrobe is about 40 percent “Life is Good” apparel and I keep a daily gratitude journal.
Despite this stockpile of good vibes and hopeful expectations, I have yet to find a ray of sunshine amid the brewing storm of regulatory change for medical devices in the European market. We’re less than a year away from the May 2020 implementation of the European Medical Device Regulation (MDR)—literally “mayday” for just about any company not already established with a CE mark or any firm large enough to have the resources to navigate the impending storm of reform.
The MDR’s changes are complex and sweeping. The increased level of scrutiny, layers of oversight, and additional regulatory requirements are so deep and daunting, we’ve heard from several clients that they’re not even attempting to maintain CE marks, much less obtain new ones, until the dust settles three to five years from mayday. Startups have basically zero chance of breaking into the European market under the MDR. Christine Scifert and Ann Dunahoo, respectively executive vice president and principal consultant of MRC/X LLC, share my concerns that the changes will squeeze out potential breakthroughs by solo entrepreneurs and small businesses.
“Small companies that have limited resources to gather the needed technical and clinical data are being negatively impacted by the MDR,” Dunahoo said.
“The upfront cost for quality system inspections, including unannounced inspections and the cost of technical documentation submission is significant, so the small businesses have to weigh the cost against the expected EU market growth to determine if this is a market they pursue,” Scifert added.
At Empirical, we’re seeing a shift in how our clients work to get their medical devices to market. It used to be common for smaller companies to first seek a CE mark and use it as a launching point for U.S. Food and Drug Administration (FDA) clearance and approval. But MDR is changing that. “I have more clients coming to me to get FDA clearance now because they can’t get into the European market. It used to be the other way around,” said Meredith May, vice president of Empirical Consulting. “Small companies with innovative plans aren’t going to even attempt to get into the EU. Now we see clients coming to the U.S. to get a 510(k) because they don’t want to keep up [with MDR]. They’re going to let their CE mark lapse and focus all their sales in the U.S.”
We’re also seeing extreme backlogs as companies work to beat deadlines to maintain their CE marks. It’s like a traffic jam in Houston as residents attempt a mass exodus from a Category 5 hurricane. May said she began advising clients to renew CE marks in 2016 to get ahead of the looming regulatory bottleneck. At that point, it was reasonable to expect it to take nine to 12 months to obtain a new CE mark. But due to the rush of companies trying to get ahead of the changes, the backlog for just renewing an existing mark has stretched to at least 18 months.
Also affecting regulatory flow: Of the 58 notified bodies in the EU, only two are currently certified to MDR. That means no other notified body can start processing applications for devices to be sold under MDR. Notified bodies are also not processing any new applications for CE marks under the existing Medical Device Directive (MDD) because of that backlog.
Back to that traffic jam: Once MDR takes effect, it’s going to get considerably larger. Backlog aside, the MDR requires new levels of documentation not just for new technology, but for devices that were historically granted CE marks.
“Devices that were previously not covered by the MDD such as cleaning, disinfection, and sterilization are now covered by the MDR,” Dunahoo explained. “Companies that have not previously documented technical documentation will now need to put together technical documentation compliant to the MDR. In some cases, these companies will have to contract with a notified body and obtain the appropriate quality certifications.”
We have yet to get clear guidance on what those quality certifications will be, May added.
“Generally speaking, every medical device has to have clinical evidence [under MDR],” May said. “They’re just starting out with the implants. Keep in mind—tongue depressors are medical devices. How do you establish clinical evidence for a tongue depressor?”
Dunahoo and Scifert cite that need for clinical data as the single most significant change stemming from this new regulation. The current MDD allows historical equivalence even for Class III devices. But under MDR, a company needs full technical documentation, which only occurs when the company owns the equivalent device.
Post-market clinical follow-up studies to gather clinical data on the actual devices are going to be required, Dunahoo said, and that data will have to be more in-depth and continuously gathered.
“The manufacturer will also have to document Periodic Safety Update Reports (PSUR), which will be posted on EUDAMED Class IIa—updated every two years—and Class IIb/III—updated annually,” Dunahoo said. “Additionally, a Summary of Safety and Clinical Performance (SSCP) for Class III and implantable devices will be required to be updated annually.”
It’s a considerable burden, even for larger companies. May predicts the trend she’s seeing of companies eschewing the EU for the U.S. will grow exponentially. Two particularly concerning possible outcomes: The U.S. market is glutted with competition, which will drive down prices and profit margins, and the potential dearth of devices for European patients.
“This is a legitimate crisis,” she said. “Imagine I need to get a knee replacement, and they can’t get artificial knees into the hospital where I live in Europe. We are facing an immediate shortage of medical devices.”
It’s a crisis stemming from a long overdue revamp of processes and procedures to better protect patient health, which is the silver lining I find in this wall of storm clouds. As is too often the case, a knee-jerk reaction to course correct immediately threatens to capsize the ship. I appreciate that the FDA solicits feedback from the industry before implementing major revisions, and strongly disagree with the European Commissioner for Health and Food Safety’s June 14 announcement that next May’s deadline is “realistic and achievable.” If the EU had negotiated these changes with the industry, we could’ve achieved a much more reasonable set of regulations that protect both patients and the market.
And that’s my humble opinion as a determined optimist. I will cling to the hope that reason will somehow prevail, and our industry will weather this storm because it is anchored by the innovation and ingenuity that fuels it.
Dawn Lissy is a biomedical engineer, entrepreneur, and innovator. Since 1998, the Empirical family of companies (Empirical Testing Corp., Empirical Consulting, LLC, and Empirical Machine, LLC) has operated under Lissy’s direction. Empirical offers the full range of regulatory and quality systems consulting, testing, small batch and prototype manufacturing, and validations services to bring a medical device to market. Empirical is very active within standards development organization ASTM International and has one of the widest scopes of test methods of any accredited independent lab in the United States. Because Lissy was a member of the U.S. Food and Drug Administration’s Entrepreneur-in-Residence program, she has first-hand, in-depth knowledge of the regulatory landscape. Lissy holds an inventor patent for the Stackable Cage System for corpectomy and vertebrectomy. Her M.S. in biomedical engineering is from The University of Akron, Ohio.
Despite this stockpile of good vibes and hopeful expectations, I have yet to find a ray of sunshine amid the brewing storm of regulatory change for medical devices in the European market. We’re less than a year away from the May 2020 implementation of the European Medical Device Regulation (MDR)—literally “mayday” for just about any company not already established with a CE mark or any firm large enough to have the resources to navigate the impending storm of reform.
The MDR’s changes are complex and sweeping. The increased level of scrutiny, layers of oversight, and additional regulatory requirements are so deep and daunting, we’ve heard from several clients that they’re not even attempting to maintain CE marks, much less obtain new ones, until the dust settles three to five years from mayday. Startups have basically zero chance of breaking into the European market under the MDR. Christine Scifert and Ann Dunahoo, respectively executive vice president and principal consultant of MRC/X LLC, share my concerns that the changes will squeeze out potential breakthroughs by solo entrepreneurs and small businesses.
“Small companies that have limited resources to gather the needed technical and clinical data are being negatively impacted by the MDR,” Dunahoo said.
“The upfront cost for quality system inspections, including unannounced inspections and the cost of technical documentation submission is significant, so the small businesses have to weigh the cost against the expected EU market growth to determine if this is a market they pursue,” Scifert added.
At Empirical, we’re seeing a shift in how our clients work to get their medical devices to market. It used to be common for smaller companies to first seek a CE mark and use it as a launching point for U.S. Food and Drug Administration (FDA) clearance and approval. But MDR is changing that. “I have more clients coming to me to get FDA clearance now because they can’t get into the European market. It used to be the other way around,” said Meredith May, vice president of Empirical Consulting. “Small companies with innovative plans aren’t going to even attempt to get into the EU. Now we see clients coming to the U.S. to get a 510(k) because they don’t want to keep up [with MDR]. They’re going to let their CE mark lapse and focus all their sales in the U.S.”
We’re also seeing extreme backlogs as companies work to beat deadlines to maintain their CE marks. It’s like a traffic jam in Houston as residents attempt a mass exodus from a Category 5 hurricane. May said she began advising clients to renew CE marks in 2016 to get ahead of the looming regulatory bottleneck. At that point, it was reasonable to expect it to take nine to 12 months to obtain a new CE mark. But due to the rush of companies trying to get ahead of the changes, the backlog for just renewing an existing mark has stretched to at least 18 months.
Also affecting regulatory flow: Of the 58 notified bodies in the EU, only two are currently certified to MDR. That means no other notified body can start processing applications for devices to be sold under MDR. Notified bodies are also not processing any new applications for CE marks under the existing Medical Device Directive (MDD) because of that backlog.
Back to that traffic jam: Once MDR takes effect, it’s going to get considerably larger. Backlog aside, the MDR requires new levels of documentation not just for new technology, but for devices that were historically granted CE marks.
“Devices that were previously not covered by the MDD such as cleaning, disinfection, and sterilization are now covered by the MDR,” Dunahoo explained. “Companies that have not previously documented technical documentation will now need to put together technical documentation compliant to the MDR. In some cases, these companies will have to contract with a notified body and obtain the appropriate quality certifications.”
We have yet to get clear guidance on what those quality certifications will be, May added.
“Generally speaking, every medical device has to have clinical evidence [under MDR],” May said. “They’re just starting out with the implants. Keep in mind—tongue depressors are medical devices. How do you establish clinical evidence for a tongue depressor?”
Dunahoo and Scifert cite that need for clinical data as the single most significant change stemming from this new regulation. The current MDD allows historical equivalence even for Class III devices. But under MDR, a company needs full technical documentation, which only occurs when the company owns the equivalent device.
Post-market clinical follow-up studies to gather clinical data on the actual devices are going to be required, Dunahoo said, and that data will have to be more in-depth and continuously gathered.
“The manufacturer will also have to document Periodic Safety Update Reports (PSUR), which will be posted on EUDAMED Class IIa—updated every two years—and Class IIb/III—updated annually,” Dunahoo said. “Additionally, a Summary of Safety and Clinical Performance (SSCP) for Class III and implantable devices will be required to be updated annually.”
It’s a considerable burden, even for larger companies. May predicts the trend she’s seeing of companies eschewing the EU for the U.S. will grow exponentially. Two particularly concerning possible outcomes: The U.S. market is glutted with competition, which will drive down prices and profit margins, and the potential dearth of devices for European patients.
“This is a legitimate crisis,” she said. “Imagine I need to get a knee replacement, and they can’t get artificial knees into the hospital where I live in Europe. We are facing an immediate shortage of medical devices.”
It’s a crisis stemming from a long overdue revamp of processes and procedures to better protect patient health, which is the silver lining I find in this wall of storm clouds. As is too often the case, a knee-jerk reaction to course correct immediately threatens to capsize the ship. I appreciate that the FDA solicits feedback from the industry before implementing major revisions, and strongly disagree with the European Commissioner for Health and Food Safety’s June 14 announcement that next May’s deadline is “realistic and achievable.” If the EU had negotiated these changes with the industry, we could’ve achieved a much more reasonable set of regulations that protect both patients and the market.
And that’s my humble opinion as a determined optimist. I will cling to the hope that reason will somehow prevail, and our industry will weather this storm because it is anchored by the innovation and ingenuity that fuels it.
Dawn Lissy is a biomedical engineer, entrepreneur, and innovator. Since 1998, the Empirical family of companies (Empirical Testing Corp., Empirical Consulting, LLC, and Empirical Machine, LLC) has operated under Lissy’s direction. Empirical offers the full range of regulatory and quality systems consulting, testing, small batch and prototype manufacturing, and validations services to bring a medical device to market. Empirical is very active within standards development organization ASTM International and has one of the widest scopes of test methods of any accredited independent lab in the United States. Because Lissy was a member of the U.S. Food and Drug Administration’s Entrepreneur-in-Residence program, she has first-hand, in-depth knowledge of the regulatory landscape. Lissy holds an inventor patent for the Stackable Cage System for corpectomy and vertebrectomy. Her M.S. in biomedical engineering is from The University of Akron, Ohio.
