Regulation (EU) 2024/1860 introduced a new requirement for manufacturers: MDR/IVDR Article 10a ‘Obligations in case of interruption or discontinuation of supply of certain devices’

This impacts both legacy and regulation devices, and became effective 10 January 2025. (Custom-made devices are excluded from this requirement.)

Under Article 10a, manufacturers must 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”. Other than in exceptional circumstances, manufacturers shall 1) provide this notice at least six months in advance, and 2) specify the reason for the interruption or discontinuation.

The Manufacturer Information Form is available in MDCG 2024-16 (Revision 0; December 2024). Further, the EU Commission provides guidance on Article 10a in its Q&A on Obligation to Inform of Device Interruption or Discontinuation (Revision 2; April 2026).

Below we provide a free procedure template in word format, which companies may incorporate into their quality system. The purpose of the procedure is to establish the process used by a manufacturer to inform the required parties of a device supply interruption or discontinuation.

Download Template

Note: updated April 2026 to reference the newly published Article 10a Decision Tree.