Version in force , Inserted +1,680 −0§
Amended by Regulation (EU) 2024/1860 32024R1860 on EUR-Lex (external, EUR-Lex) · Regulation (EU) 2024/568 32024R0568 on EUR-Lex (external, EUR-Lex)
Explanation, written by a model and checked against the cited text
A new Article 10a is added, requiring a manufacturer that anticipates an interruption or discontinuation of supply of a device, other than a custom-made device, reasonably foreseeable to cause serious harm or a risk of serious harm to patients or public health in one or more Member States, to inform the relevant competent authority and the economic operators, health institutions and healthcare professionals it directly supplies, and to state the reasons for the interruption or discontinuation, generally at least six months in advance.
The article further provides that the competent authority receiving this information must, without undue delay, notify the competent authorities of other Member States and the Commission, and that economic operators who receive such information must, without undue delay, pass it on to other economic operators, health institutions and healthcare professionals they directly supply.
Cited: Art. 10a, v2 (external, EUR-Lex)
v1 is the previous version, v2 this one.
Text from EUR-Lex
Inserted in this version 02017R0745-20250110
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. The information referred to in the first subparagraph shall, other than in exceptional circumstances, be provided at least 6 months before the anticipated interruption or discontinuation. The manufacturer shall specify the reasons for the interruption or discontinuation in the information provided to the competent authority. 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.