'Pathways Picks' June 18: The News this Week

‘Pathways Picks’ June 18: The News this Week

By David Filmore, Executive Editor, MedTech Strategist Market Pathways

Welcome to MedTech Strategist Market Pathways and to ‘Pathways Picks,’ our weekly roundup of the most important global medtech regulatory, reimbursement, and policy news.

Medtech regulatory and reimbursement realities are evolving rapidly. As a result, making sense of the full landscape of risks and opportunities in medtech has never been more complicated.

This week, MedTech Strategist is launching a publication to help industry navigate through the new pathways and checkpoints that are cropping up worldwide. MedTech Strategist Market Pathways will dig deep to provide context, perspective, data, and expert insights on the challenges facing industry and the prospects for success. (You can get a copy of our inaugural issue here to see what we are up to.)

But we also want to keep you in the loop each week on all the incremental changes in regulations, policies and processes that have such a big impact over time. To do that, there is ‘Pathways’ Picks’, our weekly roundup of medtech policy happenings that we think should be on your radar; the first edition is below. Look to the MedTech Strategist Community Blog over the next several weeks for more ‘Picks’ as we prepare for the full launch of MedTech Strategist Market Pathways. Enjoy!

Top Pick


AI meets CPT - The outcomes of the May meeting of the American Medical Association’s CPT editorial panel were posted last week, including a new category I code awarded for automated, point-of-care retinal imaging. The code is tied to IDx Technologies Inc.’s IDx-DR artificial intelligence-based system to diagnostic diabetic retinopathy, and it is an early example of, if not the first, Category I CPT code that specifically targets AI. In total, more than 40 new codes, in addition to code revisions, were approved by the panel.

EU: More MDR Alarm

Another notified body drops - There barely seems to be a day without news underscoring reasons to worry about the planned May 2020 implementation of the EU Medical Device Regulation (and even the May 2022 date for the IVD Regulation). The most recent bit: UK-based LRQA (Lloyds Register Quality Limited) disclosed its plans to drop its role as a notified body under the current Medical Device and IVD Directives, and to withdraw its application to operate under the MDR and IVDR.

The news comes as device companies are scrambling to gain new certifications under the current directives to take advantage of a grace period offered in the MDR/IVDR for some MDD/IVDD-certified devices. Industry experts are now worried that other notified bodies won’t have the capacity to take on many of LRQA’s clients, particularly within the 90-day notice period it is providing. Notified body numbers have already dropped from more than 80 to less than 60 in the past few years as standards have increased.

The development also spotlights the steep challenges notified bodies are facing under the new MDR requirements–if a large, established firm like LRQA has decided to call it quits, what are the smaller operations going to do? Only two notified bodies have been designated so far under the MDR, and zero under the IVDR. LRQA, which is known in particular for its work on IVDs, cites “recent market developments” for its actions. In addition to capacity challenges and elevated MDR standards, LRQA is also facing the unpredictability of Brexit—it was trying to establish a Netherlands-based notified-body entity, but it has now dropped that effort.


Commission stands firm - Calls of alarm are coming from many quarters, but the European Commission stood firm during a June 14 session of the Council of the EU, a key lawmaking body, in its confidence that MDR can be effectively implemented by the May 26, 2020, deadline. The MDR topic was raised during the session in response to a joint note of concern submitted by the governments of Germany and Ireland about the lack of preparedness for the oncoming regulations. They implored EU member states and the Commission to urgently work together to identify key challenges and solutions. Representatives from 21 other countries underscored the concerns during the session, and a few, including Poland and Bulgaria, explicitly called for extending the legal transition periods. But Vytenis Andriukaitis, commissioner in charge of health policies, pushed back. “May 2020 is a realistic and achievable deadline,” he told the Council. “Any change of rules at this late stage would be unfair to serious operators who have carried efforts to ensure their timely compliance.” Read the joint German-Irish note here.

EU agenda - Four new documents are up for endorsement June 20 by the EU Medical Device Coordination Group, which is tasked by the European Commission to implement the MDR and IVDR. The form for Manufacturer Periodic Safety Reports (MPSR), along with guidance documents on new requirements for patient implant cards, summaries of safety and clinical performance, and qualifications and responsibilities for the mandatory “person responsible for regulatory compliance” at each company are up for endorsement at MDCG’s closed-door meeting this week. The group will also discuss work to finalize multiple implementing acts necessary to enforce the new regulations. Read the June 20 meeting agenda here.

From FDA

Paclitaxel pow-wow - FDA will convene an advisory panel meeting on Wednesday and Thursday this week to help figure out what to make of a 2018 meta-analysis that suggested a late (two years and on) mortality increase in peripheral artery disease patients treated with paclitaxel-coated balloons and stents compared to uncoated devices. An analysis posted by FDA in advance of the meeting suggests the agency is convinced that the signal is real, but that it is unsure about its magnitude and cause. More data requirements are likely in the offing, but it doesn’t seem likely that FDA is readying to remove any products from the market. Read FDA’s pre-meeting analysis here.


Breakthrough biopsy - Bio-techne Corp.’s ExoDx Prostate IntelliScore (EPI) test is the first exosome-based liquid biopsy assay to gain an FDA Breakthrough Device Designation, the company said June 17. Its intended to support men in deciding whether or not to proceed with an initial prostate biopsy.

FDA drafts - The US agency issued two draft guidance documents in the past week, one outlining standards for the use of mouse embryo assay to assess the safety of assisted reproduction technology devices, and the other on testing for biotin interference in IVDs. Public comments on the drafts are due, respectively, on August 12 and August 13.

More To Watch

Canada consultation - Stakeholders have until Aug. 26 to comment on proposals that would strengthen Health Canada’s authorities to mandate device-makers to conduct post-market safety monitoring and analysis, and to produce annual reports on adverse events. A consultation was issued June 14, following the December 2018 announcement of Health Canada’s Action Plan on Medical Devices.


eSubs in China - Nobody likes sending or receiving boxes of regulatory submission documents but transitioning to an electronic process has not been easy for regulators around the world. China is on the cusp of making progress. Medical device registrations can be submitted electronically to China’s National Medical Product Administration without a paper copy starting June 24. That’s the official launch day for the agency’s eRPS system, which will accept initial and modification registration submissions for domestic Class III devices and most imported Class II and III devices, as well as submissions for clinical trial approvals and innovative medical device special reviews. Companies can still to choose to make paper submissions, but as of Nov. 1, the format of paper submissions will have to match the electronic filing form. NMPA’s announcement is here. (link in Chinese)

Yared to MDIC - Fresh off of his stint as chairman of AdvaMed, CVRx CEO Nadim Yared is now taking on the chairmanship of the Medicare Device Innovation Consortium, the public-private partnership that has played a central role in advancing new applications of regulatory science to FDA and CMS policies, and is in charge of the nascent National Evaluation System for health Technology (NEST). Yared served as AdvaMed board chair from 2017 to 2019 and has sat on the MDIC board since 2013.

Dates To Remember


June 24: The final transcatheter aortic valve replacement national coverage determination is due from the Centers for Medicare and Medicaid Services on a proposal that would reduce the procedural volumes required for hospitals to establish new TAVR programs.


July 2: Public comments are due on FDA’s list of patient preference-sensitive priorities – clinical areas or technologies where patient-preference data would be most helpful.


July 24: Comments are due on a consultation from the International Medical Device Regulators Forum on personalized medical devices, including 3D-printed devices.

Did you find ‘Pathways’ Picks: The News this Week’ valuable? Subscribe to MedTech Strategist’s newest industry publication, MedTech Strategist Market Pathways today and let us help you answer the questions that will shape your global regulation, reimbursement, and market access strategy.

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Further Reading in MedTech Strategist Market Pathways:

  • “IDx Technologies: AI Meets Market Access with a Breakthrough Diabetic Retinopathy Detection Device,” by Tracy Schaaf

  • “EUMDR: Welcome to the New Reality,” by Stephen Levin


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