Requirement to Report Supply DisruptionsRequirement to Report Supply DisruptionsRequirement to Report Supply DisruptionsRequirement to Report Supply Disruptions
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Regulation 2024/1860 Published
July 17, 2024

Requirement to Report Supply Disruptions

July 17, 2024

The requirement to notify of foreseeable supply disruptions (including discontinuation) goes into effect, under Article 10 of the MDR/IVDR.

 

Key Points:

  • This is required when it is reasonably foreseeable that a supply interruption may result in serious harm or a risk of serious harm to patients or public health, in one or more Member States.
  • At least six (6) months’ advance notice must be given, before the anticipated interruption.
  • The manufacturer should notify all relevant parties. These include, but are not limited to, their (or their Authorized Representative’s) Competent Authority, importers, distributors, health institutions, and healthcare professionals.
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