MDR/IVDR reforms require adoption by the European Parliament, referencing US FDA pre-submission meetings.

The entities involved

• European Commission →

  executive branch of the European Union

  • The European Commission aims to strengthen homegrown AI capabilities while global advanced models face usage restrictions.Mon 17:49
  • The European Commission has initiated economic support measures for Armenia, including funding transfers, trade program development, and import restrictions.Mon 17:26
• European Parliament →

  parliament of the European Union directly elected by the citizens of the Union

  • MEPs in the European Parliament debated Russia's hybrid attacks on September 14, 2026.Mon 15:57
  • A company, Trifork Group AG, whose headquarters is in Schindellegi, Switzerland, is conducting a share buyback governed by EU financial law.Mon 15:36
• FDA →
  • Generic medicine services are seeking approval for launch from the FDA.Mon 17:49
  • A company is seeking FDA feedback on its NEO212 program, with a meeting scheduled at the FDA's White Oak campus.Mon 14:56

Related events

• Both the FDA and the European Medicines Agency govern drug approval processes.Aug 12
• A 2019 finding indicated that the US regulatory process was slower than European standards.Jul 30
• Congress considered proposals to strengthen FDA authority regarding medical device regulation and minimum standards.Jun 7
• The FDA and European Medicines Agency are harmonizing regulatory review of drug applications.Sep 17
• FDA rule changes are causing delays in product approval, leading to the process exceeding Congressional mandated timeframes.Thu 15:32