EU Shortage Reporting Guide, Upcoming Medicare Rules, and More

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ARTICLE SUMMARY:

In this week’s Pathways Picks: Europe issues a guidance laying out expectations for a pending mandate to disclose anticipated shortages, and documents addressing ethylene oxide regulation and the upcoming Health Technology Assessment regulation; 2025 Medicare payment rules are imminent; FDA meetings and guidelines; and developments in China and Brazil.

EU Picks

Shortage reporting guidance, EtO details, and HTA updates:

Supply disruption guidance. The European Commission issued an eagerly anticipated guidance October 30 laying out its thinking, in a Q&A format, about how new requirements for device companies to disclose expected device shortages will be implemented. The guide addresses the mandate enacted earlier this year for manufacturers to inform national competent authorities, health institutions, and distributors/importers six months before supply of a product is “interrupted or discontinued” in a manner that “could result in serious harm or a risk of serious harm to patients or public health.” Notably, the new guide affirms that the EU will not provide a list of specific devices subject to the requirements, but that it will be up to companies to determine when the “serious harm or risk” threshold is met on a case-by-case basis. The guidance also clarifies:

  • What qualifies as an interruption: The “temporary inability” to place a specific device on the market, “with an expected duration of more than 60 days.”
  • Procedures for cascading the shortage information: Manufacturers must only notify organizations they directly supply and distributors must pass the information along “without changing, adding to or paraphrasing”
  • There is some leeway to disclose the shortage within six months in “exceptional circumstances.”
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