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1. In order to facilitate the monitoring referred to in Article 23, the Agency may request a Member State to:

(a) submit the set of information referred to in Article 25(2), point (d), 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 21(5), second subparagraph, using the monitoring and reporting methods and systems established pursuant to Article 25(1), point (b);

(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);

(c) 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.

2. For the purposes of paragraph 1, Member States shall gather information from manufacturers of medical devices and their authorised representatives, healthcare providers, importers and distributors, as applicable, and notified bodies on medical devices included on the public health emergency critical devices list.

3. Where Member States have any information in addition to the information to be provided in accordance with paragraphs 1 and 2 of this Article, which provides evidence of an actual or potential shortage of medical devices, they shall immediately provide such information to the MDSSG through their respective single point of contact referred to in Article 21(5), second subparagraph.

4. Following the reporting on the results of the monitoring referred to in Article 23 and any recommendations on preventive or mitigating measures provided in accordance with Article 24, Member States shall:

(a) consider the need to provide for temporary exemptions at Member State level pursuant to Article 59(1) of Regulation (EU) 2017/745 or Article 54(1) of Regulation (EU) 2017/746 with a view to mitigating actual or potential shortages of medical devices included on the public health emergency critical devices list while ensuring a high level of patient and product safety;

(b) take into account any recommendations referred to in Article 24(3) and any guidelines referred to in Article 28, point (b), and coordinate their actions in relation to any actions taken at Union level pursuant to Article 28, point (a);

(c) inform the MDSSG of any measures taken and report on the results of the actions referred to in point (b), including providing information on the resolution of the actual or potential shortage of medical devices concerned.

For the purposes of the first subparagraph, points (b) and (c), Member States that take an alternative course of action at national level shall share the reasons for doing so with the MDSSG. The recommendations, guidelines and actions referred to in the first subparagraph, point (b), of this paragraph, and a summary report of the lessons learned shall be made publicly available via the web portal referred to in Article 29.