ARTICLE SUMMARY:
December is starting off strong in the medtech policy space. Actions on an EU MDR grace period, the Eudamed database, the FDA commissioner nominee, and ethylene oxide sterilization are the top items to watch this week, according to MedTech Strategist Market Pathways.
[For a complete roundup of medtech policy happenings that should be on your radar this week and deeper analysis of the sector, check out Market Pathways.]
The first week of December is starting off with a bang in the medtech policy world on both sides of the Atlantic. Here are four key developments, two from the EU and two from the US, that you should have on your radar this week.
EU grace period. An extended transition period written into the European Union Medical Device Regulation will be applicable to more devices, including many software products, under an amendment to the MDR approved by a EU Parliament committee this week. The widely anticipated corrigendum, expected to be adopted by the full Parliament and EU Council soon, will grant devices that are considered low-risk, Class I products not requiring a notified body assessment under current EU directives, but that will require such an assessment under the new MDR up to four years of extra leeway to undergo notified body oversight—i.e., CE marks under the current directives can be used to market a product until they expire or May 2024, whichever comes first. That creates parity with the grace period available to devices that have historically needed sign off by notified bodies. No devices are exempted from the MDR’s new post-market surveillance requirements starting May 26, 2020, and the grace period is voided if a manufacturer makes a “significant change” to a marketed device.
Pushback on Eudamed delay. The European Commission’s decision in October to delay launch of the new Eudamed database until 2022 is causing unease among the national regulatory agencies for the EU member states. The national competent authorities say they are left to implement burdensome, transitional solutions to support compliance with the new Medical Device Regulation starting next year in the absence of the centralized EU database for registration of companies, devices, and other information. “The postponement of Eudamed as a whole and the simultaneous retention of the validity of the MDR raises many operational and enforcement questions and also raises challenges to transparency, confidence in regulatory framework and security of operation,” the Competent Authorities for Medical Devices (CAMD) organization writes in a November 28 open letter. CAMD urges the commission to work with EU country authorities to determine a workable solution. The issue was the focus at a gathering of the commission’s Medical Device Coordination Group (MDCG) November 21, and it is on the agenda for the MDCG’s next meeting in Brussels on December 13. There is also word that Eudamed challenges will be discussed at the Council of the EU—the EU legislative body that represents European heads of state—when the key committee of jurisdiction meets next week in Brussels.
One step from a new FDA commissioner. Stephen Hahn’s nomination to serve as the next commissioner of the US FDA was voted favorably out of the Senate Health, Education, Labor and Pensions Committee December 3 on an 18-5 vote. HELP Chairman Lamar Alexander (R-TN) says he hopes the full Senate will officially confirm Hahn, who is a radiation oncologist and the chief medical executive of the MD Anderson Cancer Center in Texas, before the end of the year. The five Democrats who voted against Hahn include HELP’s top Democrat Sen. Patty Murray (D-WA).
EPA up next in EtO narrative. The US Environmental Protection Agency’s technology review and advanced notice of proposed rulemaking on emissions standards for industrial ethylene oxide (EtO) sterilization facilities could be issued any day, now that the White House Office of Management & Budget has completed review of the measure. The document could influence ongoing debates at the state level about the need to curb ethylene oxide sterilization to reduce cancer risks from emissions—leading to some plant shutdowns and risks of medical device shortages. The EPA action is coming soon after FDA announced, on November 25, several steps designed to counter the current pressure on EtO sterilization capacity, including a pilot program that would allow sterilizers to submit a “master file” to FDA documenting process changes that device firms could refer to rather than having to file separate FDA submissions to support adjustments that might reduce use of EtO. FDA also announced the 12 companies selected for its two “innovation challenges” to reduce EtO emissions and come up with new sterilization methods, and says it is working with companies to reduce the amount of paper, such as labeling and instructions, included inside sterile packaging to reduce the amount of EtO needed to sterilize certain devices.
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