Anticipation (of an interruption or discontinuation of supply)

Under Article 10a of the MDR and IVDR, added by Regulation (EU) 2024/1860, this moment starts the obligation to inform authorities and others. The Q&A makes clear that it includes analyzing the problem and planning mitigation and communication, so the timeline starts once the decision is confirmed, not at the first rumor.

In this context, “anticipation” should be understood to mean that the manufacturer confirms that an interruption or discontinuation of a device supply will occur. This ‘confirmation’ includes the analysis of the problem or business decision at hand, the evaluation of mitigation measures in operations and in the supply chain as well as the development of appropriate communication strategies for stakeholders to be addressed.

Q&A on the Article 10a obligation in case of interruption or discontinuation of supply (Regulation (EU) 2024/1860), rev.2, Question 7