1.

In order to facilitate the monitoring referred to in Article 23, the Agency may request a Member State to: submit the set of information referred to in Article 22(2), including available information about needs related to the medical devices included in the public health emergency critical devices list, and available and estimated data on volume of demand and demand forecasts for those medical devices, through the respective single point of contact referred to in Article 25(2), point (a), and using the monitoring and reporting methods and systems established pursuant to Article 25(1), point (b); indicate the existence of any commercially confidential information and explain why that information is of a commercially confidential nature, in accordance with Article 26(3); indicate any failure to provide requested information and whether there are any delays in providing that information by the deadline set by the Agency in accordance with Article 26(2). Member States shall comply with the Agency’s request by the deadline set by the Agency.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-06 · Text as adopted (Official Journal); later amendments are not incorporated in this text.