Article 10a: Obligations in case of interruption or discontinuation of supply of certain devices

1.   Where a manufacturer anticipates an interruption or a discontinuation of the supply of a device, other than a custom-made device, and where it is reasonably foreseeable that such interruption or discontinuation could result in serious harm or a risk of serious harm to patients or public health in one or more Member States, the manufacturer shall inform the competent authority of the Member State where it or its authorised representative is established, as well as the economic operators, health institutions and healthcare professionals to whom it directly supplies the device, of the anticipated interruption or discontinuation.

2.   The competent authority that has received the information referred to in paragraph 1 shall, without undue delay, inform the competent authorities of the other Member States and the Commission of the anticipated interruption or discontinuation.

3.   The economic operators who have received the information from the manufacturer in accordance with paragraph 1 or from another economic operator in the supply chain shall, without undue delay, inform any other economic operators, health institutions and healthcare professionals to whom they directly supply the device, of the anticipated interruption or discontinuation.