Report an interruption or discontinuation of supply of certain medical devices and certain in vitro diagnostic medical devices
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 provides in Article 2, paragraph 1, the following:
‘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’.
download document – Regulation (EU) 2024/1860 
Thus, Romanian manufacturers are obliged to inform the NAMMDR as well as economic operators, health institutions and healthcare professionals to whom they directly supply a device about the anticipated interruption or discontinuation of its supply.
The information shall be provided, except in exceptional circumstances, at least six months before the anticipated interruption or discontinuation. The manufacturer shall state the grounds for the interruption or discontinuation in the information provided to the competent authority.
Exceptional circumstances arise when a manufacturer cannot anticipate or confirm an interruption or discontinuation of supply at least six months before it occurs. This may include cases where the interruption or discontinuation occurs due to sudden and unexpected external or internal circumstances. For example, a disaster, an interruption due to a sudden inability to obtain raw materials or components, or an interruption due to unexpected circumstances, including of economic or financial nature.
The NAMMDR shall inform competent authorities of the other Member States and the Commission about the anticipated interruption or discontinuation and economic operators who have received the information from the manufacturer or from another economic operator in the supply chain shall inform, without undue delay, any other economic operators, health institutions and healthcare professionals to whom they directly supply the device, about the anticipated interruption or discontinuation.
These provisions apply from 10 January 2025, as defined in Article 3 of Regulation 2024/1860.
The European Commission has published the Questions and Answers Guideline on practical aspects related to the implementation of the Article 10a obligation in case of interruption or discontinuation of supply of certain devices as introduced by Regulation (EU) 2024/1860 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.
download document – Q&A Guideline
Manufacturer Information Form on Interruption or Discontinuation of Supply of certain medical devices and certain in vitro diagnostic medical devices
download document – Annex to form – device identification table
After filling in the form and the related Annex, these shall be sent electronically to the e-mail address: drsp@anm.ro.