New Q&A on the obligation to inform in case of interruption or discontinuation of supply

Some key takeaways from the Q&A

With the exception of custom-made devices, Article 10a will apply as of 10 January 2025 to all models or types of devices including legacy devices, and the legal manufacturer cannot delegate its legal responsibility for this task, however it can engage the assistance of its authorised representative, other economic operators or a third party, in the practical implementation of the required operational tasks. The notified economic operators are responsible to cascade the information as provided by the legal manufacturer to downstream supply chain.

The Q&A also includes an example of the onward information sharing in the context of a supply interruption where the manufacturer does not directly supply to the health institution. In addition, information is provided on the timelines on when the manufacturer should inform under Article 10a.

Further, the Q&A provides clearer definitions and examples for “exceptional circumstances”, “anticipation of an ‘interruption or discontinuation’ of the supply of a device” and “interruption or discontinuation that may result in serious harm or a risk of serious harm to patients or public health”. The document also provides information on which indicators the manufacturer can take into account when performing its assessment.

In the future, the manufacturer must provide information as required in the “ Manufacturer Information Form”, which is currently not available yet. It should be noted that Member States may provide additional information on how to submit the information in the form, on the websites of the relevant competent authority.

Lastly, the Q&A provides clarity that Article 10a applies to manufacturers of individual CE-marked devices within a system or procedure pack. These manufacturers are responsible for informing the relevant parties, as outlined in Article 10a (1) of the MDR/IVDR, including the competent authority and the system or procedure pack producer, about any interruption or discontinuation of their devices.

What does it mean to you?

The Q&A document assists IVD and medical device manufacturers in addressing questions related to the new supply interruption notification requirements in Regulation (EU) 2024/1860. Developed with the amendment’s objectives in mind, it clarifies manufacturers’ information-sharing obligations introduced in Article 10a.

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