1. In order to facilitate the monitoring referred to in Article 23, the Agency may request manufacturers of medical devices, or their authorised representatives, as applicable, and, if appropriate, importers and distributors, included on the public health emergency critical devices list and, where necessary, relevant notified bodies, to submit the information requested by a deadline set by the Agency.
The manufacturers of medical devices, or their authorised representatives, as applicable, and, if appropriate, importers and distributors, referred to in the first subparagraph, shall submit the requested information through the single points of contact referred to in Article 25(2), point (a), using the monitoring and reporting systems established pursuant to Article 25(1), point (b). They shall provide updates where necessary.
2. Manufacturers of medical devices, or their authorised representatives, as applicable, notified bodies and, if appropriate, importers or distributors shall justify any failure to provide requested information and any delays in providing requested information by the deadline set by the Agency.
3. Where manufacturers of medical devices, or their authorised representatives, notified bodies, or, if appropriate, importers or distributors indicate that the information that they submitted contains information of a commercially confidential nature, they shall identify the relevant parts of that information having such nature and explain why that information is of a commercially confidential nature.
The Agency shall assess the merits of each indication of information as being of a commercially confidential nature and protect such commercially confidential information against unjustified disclosure.
4. Where manufacturers of medical devices, or their authorised representatives, notified bodies, or, if appropriate, importers or distributors have any information in addition to that required under paragraph 1, which provides evidence of an actual or potential shortage of medical devices, they shall immediately provide such information to the Agency.
5. 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, manufacturers of medical devices, or their authorised representatives, and, if appropriate, importers and distributors referred to in paragraph 1, shall:
(a)
provide any comments they have to the Agency;
(b)
take into account any recommendations referred to in Article 24(3) and (4) and any guidelines referred to in Article 28, point (b);
(c)
comply with any measures taken at Union or Member State level pursuant to Article 27 or 28;
(d)
inform the MDSSG of any measures taken and report on the results of those measures, including providing information on the resolution of the actual or potential shortage of medical devices.
6. Where manufacturers of medical devices referred to in paragraph 1 are established outside the Union, the information requested in accordance with this Article shall be provided by the authorised representatives, or, if appropriate, by importers or distributors.