3.

The information referred to in paragraph 2, point (c), shall include at least: the name of the manufacturer of the medical device and, if applicable, the name of its authorised representative; the information identifying the medical device and the intended purpose and where necessary, specific characteristics of the medical device; if applicable, the name and number of the notified body and information regarding the relevant certificate or certificates; 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; sales and market share data of the medical device; available stocks of the medical device; the forecast of supply of the medical device, including information on the potential vulnerabilities in the supply chain; quantities already delivered and projected deliveries of the medical device; the demand forecasts for the medical device; shortage prevention and mitigation plans that include, at a minimum, information on production and supply capacity; 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; 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; 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.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-06 · Text as adopted (Official Journal); later amendments are not incorporated in this text.