Pathways' Pick of the Week: EU Medtech Seeks Reforms

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MedTech Europe calls for comprehensive MDR and IVDR reforms. Excerpted from Pathways Picks November 8: EU Reform, Medicare Rules, Cyber Picks, and More.

MedTech Europe doubled down and expanded on demands for “comprehensive reform” of the EU Medical Device and IVD Regulations in a position paper published November 7. “While considerable work has been done by all stakeholders to address the short-term implementation challenges, there are structural issues in the regulatory system which make it slow, unpredictable, costly and complex, and lacking in agile pathways for innovation,” the trade group writes. The paper reaffirms some reform requests outlined in an open letter sent in September to the EU Health Commissioner by 34 organizations including MTE and adds more changes for consideration. Key reforms floated by the industry trade association include:

  • Allowing notified bodies to be more flexible in weighing benefits and risk when assessing devices
  • Removing the need to recertify devices under the MDR and IVDR
  • Allowing pre-submission dialogues with notified bodies
  • Establishing accelerated and precertification pathways
  • Building more centralized governance for addressing systematic regulatory issues
Continue reading Pathways’ Picks here.

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Pathways’ Picks December 6: EU Roundup, Medicare Snags, LDT Input Rushes In

In this week’s roundup: The EU puts notified bodies on notice, renews calls for “structured dialogue,” launches a manufacturer survey, finally rolls out IVD reference lab plans; in the US, the Medicare Breakthrough Device bill hits a budgetary snag, FDA gets thousands of LDT proposed rule comments and opens its eSTAR template to PMAs; and more from Europe, the US, and China.

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