What does Article 10a mean for the industry?

Article 10a of the MDR/IVDR came into effect on the 10^th January 2025, but what does this mean for importers and distributors of medical devices and in-vitro diagnostics?

Article 10a rule obliges manufacturers to notify EU authorities and their customers in advance of supply interruptions and product device discontinuations if these could pose a risk of severe harm to patients

The information obligation regarding an anticipated interruption or discontinuation of device supply in Article 10a of the MDR/IVDR is intended to have a cascading effect. The information originating from the manufacturer, should be passed to other economic operators in the downstream supply, until it reaches the relevant health institutions, or healthcare professionals.

Relevant economic operators therefore who have received information from the manufacturer under Article 10a(1) of the MDR/IVDR or another economic operator in the supply chain (e.g. from importers or distributors), are expected to further share this information ‘without undue delay’ with other economic operators, health institutions and healthcare professionals to whom they directly supply the device. It is expected that economic operators do not change, add to or paraphrase the communication received from the manufacturer so as to preserve its integrity.

Ref; Q&A Obligation to inform in case of interruption or discontinuation of supply published on https://health.ec.europa.eu/