List of critical medical devices and information to be provided
Article 22
1. Immediately following the recognition of a public health emergency, the MDSSG shall consult the working party referred to in Article 21(5). Immediately following that consultation, the MDSSG shall adopt a list of categories of critical medical devices which it considers to be critical during the public health emergency (‘public health emergency critical devices list’). To the extent possible, relevant information on critical medical devices and related manufacturers shall be gathered from Eudamed, once it is fully functional. The information shall also be gathered from importers and distributors, as appropriate. Until Eudamed is fully functional, available information may also be gathered from national databases or other available sources. The MDSSG shall update the public health emergency critical devices list whenever necessary until the termination of the recognition of the public health emergency. 2. For the purposes of Article 25(2), the MDSSG shall adopt and make publicly available the set of information referred to in Article 25(2), points (b) and (c), that is necessary to monitor the supply of and demand for medical devices included on the public health emergency critical devices list, and inform the working party referred to in Article 21(5) of that set of information. 3. The Agency shall publish on a dedicated webpage on its web portal: (a) the public health emergency critical devices list, as well as any updates to that list; and (b) information on actual shortages of critical medical devices included on the public health emergency critical devices list.