In Vitro Diagnostic Medical Devices Regulation

INSERTED +1,645 −0 Art. 10a Obligations in case of interruption or discontinuation of supply of certain devices§

applies from: unknown (an inserted provision states its own application date only in prose)

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

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.

MODIFIED ±0 Art. 74§

applies from: unknown

Sources disagree — the amending act's instructions found this change; the text comparison finds no difference in the provision's text and the EU's own amendment metadata does not list it. All are shown; none is overruled.

No explanation shipped — the structural diff did not see this change, so it carries no text; another signal named the unit and the disagreement ships as `disputed`.

MODIFIED ±0 Art. 110§

applies from: unknown

Sources disagree — the amending act's instructions found this change; the text comparison finds no difference in the provision's text and the EU's own amendment metadata does not list it. All are shown; none is overruled.

No explanation shipped — the structural diff did not see this change, so it carries no text; another signal named the unit and the disagreement ships as `disputed`.

MODIFIED ±0 Art. 112§

applies from: unknown

Sources disagree — the amending act's instructions found this change; the text comparison finds no difference in the provision's text and the EU's own amendment metadata does not list it. All are shown; none is overruled.

No explanation shipped — the structural diff did not see this change, so it carries no text; another signal named the unit and the disagreement ships as `disputed`.

MODIFIED ±0 Art. 113§

applies from: unknown

Sources disagree — the amending act's instructions found this change; the text comparison finds no difference in the provision's text and the EU's own amendment metadata does not list it. All are shown; none is overruled.

No explanation shipped — the structural diff did not see this change, so it carries no text; another signal named the unit and the disagreement ships as `disputed`.