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Made by Regulation (EU) 2024/1860 32024R1860 on EUR-Lex

Regulation (EU) 2024/1860 of the European Parliament and of the Council of 13 June 2024 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, the obligation to inform in case of interruption or discontinuation of supply, and transitional provisions for certain in vitro diagnostic medical devices (Text with EEA relevance)

Version 6 of 6 recorded for IVDR, the newest.

First seen by emendrix on , when it first read this version; that is not a legal date.

1 change in this version

  • All explained

What these mean

Consolidated versions 02017R0746-20240709 → 02017R0746-20250110. v1 is the previous version, v2 this one.

Everything Regulation (EU) 2024/1860 changed · also changed Medical Devices Regulation

What changed

Art. 10a Obligations in case of interruption or discontinuation of supply of certain devices Inserted

+1,645 −0 characters · Applies from: not readable (an inserted provision states its own application date only in prose) why

Twin in Medical Devices Regulation: Art. 10a, textually similar (0.981), paired on this act's text of 10 January 2025 and the Medical Devices Regulation text of 19 July 2026. The same amending act changed it: yes. See where the two texts differ.

Explanation, written by a model and checked against the cited text

A new Article 10a is added, requiring a manufacturer who anticipates that supply of a device will be interrupted or discontinued, and who considers this could foreseeably cause serious harm or a risk of serious harm to patients or public health in one or more Member States, to inform the competent authority of the Member State where it or its authorised representative is established, along with the economic operators, health institutions and healthcare professionals it directly supplies.

This notification is to be given at least six months before the anticipated interruption or discontinuation except in exceptional circumstances, and must state the reasons for it, with the receiving competent authority then informing other Member States' competent authorities and the Commission without undue delay.

Economic operators who receive this information are in turn required to pass it on without undue delay to any other economic operators, health institutions and healthcare professionals they directly supply.

Cited: Art. 10a, v2

v1 is the previous version, v2 this one.

Text from EUR-Lex

Inserted in this version 02017R0746-20250110

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 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.

The full entry is committed at eu/32017R0746/CHANGELOG.md.