Role of the Commission regarding the monitoring and mitigation of shortages of medical devices
Article 28
The Commission shall take into account the information from and recommendations of the MDSSG and shall: (a) take all necessary action within the limits of the powers conferred on the Commission, with a view to mitigating actual or potential shortages of medical devices included on the public health emergency critical devices list, including, where necessary, granting temporary exemptions at Union level pursuant to Article 59(3) of Regulation (EU) 2017/745 or Article 54(3) of Regulation (EU) 2017/746, while respecting the conditions set out in those Articles and seeking to ensure both patient and product safety; (b) consider the need for guidelines and recommendations to be addressed to Member States, manufacturers of medical devices, notified bodies, and other entities, where relevant; (c) request the MDSSG to provide recommendations or coordinate measures provided for in Article 24(3), (4) and (5); (d) consider the need for medical countermeasures in accordance with Decision No 1082/2013/EU and other applicable Union law; (e) liaise with third countries and relevant international organisations, as appropriate, to mitigate actual or potential shortages of medical devices included on the public health emergency critical devices list or their component parts, where those devices or parts of such devices are imported into the Union, and where such actual or potential shortages have international implications, and report on any related actions as well as the results of those actions to the MDSSG, where relevant.