MDR/IVDR Article 10a Requirement to Report Supply Disruptions Takes Effect Today

Article 10a, newly introduced under Regulation (EU) 2024/1860, goes into effect today.

MDR/IVDR Article 10a requires that manufacturers notify relevant parties when an interruption or discontinuation is reasonably foreseeable, and could result in “harm or a risk of serious harm to patients or public health in one or more Member States”. It applies to both Regulation and Legacy devices.

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.

Resources:

• The Manufacturer Information Form is available in in MDCG 2024-16.
• The Commission published guidance on Article 10a in its Q&A on the Obligation to Inform of Device Interruption or Discontinuation.
• Casus is making available a free, word format procedure template for download: MDR/IVDR Article 10a Procedure Template

Note that Swissmedic announced 1 January 2025, that Article 10a has not been incorporated into its recent legislative amendment.