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1. In order to prepare for the fulfilment of the tasks referred to in Articles 22, 23 and 24, the Agency shall:

(a) specify the procedures and criteria for establishing and reviewing the public health emergency critical devices list.;

(b) develop streamlined IT monitoring and reporting systems, in coordination with the relevant national competent authorities, that facilitate interoperability with existing IT tools and Eudamed, once it is fully functional, and provide the adequate support to national competent authorities for monitoring and reporting;

(c) establish the working party referred to in Article 21(5) and ensure that each Member State is represented on that working party;

(d) specify the methods for the provision of recommendations referred to in Article 24(3) and (4) and for the coordination of measures referred to in Article 24. For the purposes of the first subparagraph, point (a), the MDCG, representatives of manufacturers, other relevant actors in the supply chain for the medical device sector and representatives of healthcare professionals, of patients and consumers may be consulted as necessary.

2. Following the recognition of a public health emergency, the Agency shall:

(a) establish a list of single points of contact for the manufacturers of medical devices, or their authorised representatives, importers and notified bodies, for the medical devices included on the public health emergency critical devices list;

(b) maintain the list of single points of contact referred to in point (a) for the duration of the public health emergency;

(c) request relevant information on medical devices included on the public health emergency critical devices list from the single points of contact referred to in point (a) on the basis of the set of information adopted by the MDSSG and set a deadline for the submission of that information;

(d) request relevant information on medical devices included on the public health emergency critical devices list from the single points of contact referred to in Article 21(5), second subparagraph, on the basis of the set of information adopted by the MDSSG in accordance with Article 22(2) and set a deadline for the submission of that information.

The Agency may use sources other than those referred to in the first subparagraph, including existing databases and databases in development, to gather information required under paragraph 3. For the purposes of the first subparagraph, point (a), where it is considered relevant, national or Union databases, including Eudamed, once it is fully functional, or medical device associations may be used as sources of information.

3. The information referred to in paragraph 2, point (c), shall include at least:

(a) the name of the manufacturer of the medical device and, if applicable, the name of its authorised representative;

(b) the information identifying the medical device and the intended purpose and where necessary, specific characteristics of the medical device;

(c) if applicable, the name and number of the notified body and information regarding the relevant certificate or certificates;

(d) details of the actual or potential shortage of the medical device, such as actual or estimated start and end dates and the suspected or known cause;

(e) sales and market share data of the medical device;

(f) available stocks of the medical device;

(g) the forecast of supply of the medical device, including information on the potential vulnerabilities in the supply chain;

(h) quantities already delivered and projected deliveries of the medical device;

(i) the demand forecasts for the medical device;

(j) shortage prevention and mitigation plans that include, at a minimum, information on production and supply capacity;

(k) information from relevant notified bodies regarding their capacity to process applications and carry out and complete conformity assessments in relation to medical devices included in the public health emergency critical devices list, within an appropriate period of time considering the emergency;

(l) information on the number of applications received by relevant notified bodies in relation to medical devices included in the public health emergency critical devices list and on the relevant conformity assessment procedures;

(m) where conformity assessments are ongoing, the status of the conformity assessment by the relevant notified bodies in relation to medical devices included in the public health emergency critical devices list and possible critical issues on the final outcome of the assessment and which need to be considered in order to complete the conformity assessment process.

For the purposes of the first subparagraph, point (k), the relevant notified bodies shall communicate the date by which the assessment is expected to be completed. In that regard, notified bodies shall prioritise conformity assessments of medical devices included in the public health emergency critical devices list.