ARTICLE SUMMARY:
In this week’s pick from Market Pathways, editor David Filmore makes the case for redoubling medtech regulatory global harmonization efforts in the wake of the COVID-19 crisis.
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If this global pandemic is not a shot in the arm to medtech global harmonization efforts, then what will be?
A pandemic by its very nature is a shared problem faced by a large swath of the globe all at once. The world is looking to the tools of medtech to help resolve it. But as the virus sweeps around the globe, these tools, including diagnostic tests and other technologies, are disparately deployed country-by-country, leading to delays and inefficiencies that escalate the crisis.
While the World Health Organization has been a prominent global voice, and played an important role, for instance, in validating an initial COVID-19 test, it is has become abundantly clear that there is no shared global strategy for bringing medtech to bear on this most challenging of healthcare challenges. There are multiple modes of government failure that have led to our current predicament, and many of them fall above the pay grade of a medtech regulator. But COVID-19 puts into stark relief how a framework that more readily allows assessment of medical devices and diagnostics performed in one country to be trusted in other countries would help a great deal.
Medtech regulators around the world have earnestly elevated the goals of global convergence and harmonization as priorities in recent years. And important progress has been made. Foundational international standards form the basis of many device development and production processes, including some the mad-dash modifications and scale-ups that are happening in response to the current crisis. And the International Medical Device Regulators Forum has been busy churning out guidelines, describing shared approaches that countries can adopt for basic regulatory functions.
IMDRF’s most successful project to date has been the Medical Device Single Audit Program, a growing initiative that allows accredited auditors to sign off on certain quality or regulatory requirements for five different countries at once. While onsite facility audits are largely on hold during this period of social distancing, MDSAP auditors have adapted to remote audit processes, a step that is contributing in some small way to a multi-country shared regulatory response.
What’s more, COVID-19 has at least temporarily expanded the global reach of MDSAP. The five participating countries in the program are the US, Canada, Brazil, Australia, and Japan. Europe, busy rethinking its own internal device regulatory processes, has been prominently absent from the project, only recently joining as an “observer” to MDSAP. But in emergency recommendations issued last week, the European Commission stated that “MDSAP audits …in lieu of Directive audits” are one appropriate temporary alternative to support device recertifications or modifications (and, potentially, in very limited COVID-19 emergency situations, for initial device certifications) while onsite notified body audits are largely halted to minimize viral spread.
If Europe retains some small level of acceptance of MDSAP audits after onsite visits can eventually resume, it will be one very tangible example of the pandemic forwarding the cause of global medtech harmonization.
But more work is needed. Fundamental alignment on other aspects of pre-market device review, which could support something like a global “single review” program for some devices, is a heavier lift. Global regulators, working under the auspices of IMDRF, have in recent years taken steps toward development of what they are calling a Medical Device Single Review Program. Just last month, IMDRF issued the latest two draft documents in a series of consultations laying out guidelines for the operation of “conformity assessment bodies” that could ultimately form the basis of such a program.
FDA’s device chief Jeff Shuren, among others, has championed this concept. But FDA has run into pushback when it has attempted to insert specific elements of IMDRF recommendations into official agency guidance. The types of reforms that Shuren has suggested would be necessary for the US system to truly engage in a single-review program—things like a conditional “progressive” approval pathway—are controversial.
But the global national emergency we are facing puts everything in a new light. It will be crucial to take the myriad shortcomings that are spotlighted in this ongoing tragedy and take them to heart, learning lessons to improve our systems’ ability to respond to emergencies like this and the vast healthcare challenges that the world already faced in the absence of a pandemic. Accelerating a framework for greater global convergence of medtech regulatory standards seems like one worthy response.
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