On October 30, 2024, a Q&A was published regarding a gradual roll-out of Eudamed, to obligation to inform in case of interruption or discontinuation of supply, and the transitional provisions for certain in vitro diagnostic medical devices, in connection with Article 10a inserted in (EU) 2024/1860 (amended on June 30, 2024). This Q&A concerns the obligation to notify the discontinuation or interruption of supply for certain medical devices as defined in the MDR and IVDR.
Certain medical devices, excluding custom-made devices, are those types of medical devices placed on the EU market, where it is reasonably foreseeable that the interruption or discontinuation of supply in one or more member states could cause serious harm to, or create a serious risk of harm to, patient or public health.
The regulations regarding the obligations when the supply of specific devices is interrupted or discontinued, as stated in Article 10a of (EU) 2024/1860 amended on June 30, 2024, are as follows:
1) If a manufacturer (established within the EU or overseas) anticipates the discontinuation or interruption of supply of a non-customized device, and it is reasonably foreseeable that such interruption or discontinuation would result in serious harm or a risk of serious harm to patients or public health in one or more EU Member States, the manufacturer shall inform the competent authority of the Member State where it or its authorized representative is established. Additionally, they shall inform the economic operator directly supplying the device, health institutions and healthcare professionals of the anticipated interruption or discontinuation.
This information should be provided at least six months before the anticipated supply disruption or interruption, unless it is an exceptional situation. The manufacturer must also specify the reasons for the interruption or discontinuation when providing this information to the relevant authorities.
2) Upon receiving the information mentioned in 1), the relevant authority must promptly inform the relevant authorities of other Member States and the European Commission about the anticipated interruption or discontinuation.
3) Economic operators who receive information under 1) from the manufacturer or other economic operators within the supply chain shall promptly inform other economic operators directly supplying the medical device, health institutions, and healthcare professionals of the anticipated interruption or discontinuation.
This regulation will apply starting January 10, 2025. If a manufacturer anticipates a supply interruption or discontinuation of a medical device before January 10, 2025, but the event occurs after that date, it will not be mandatory to report it. However, it is recommended that manufacturers voluntarily inform medical device users of the anticipated supply interruption or discontinuation.
Please refer to the link below.
Q&A Obligation to inform in case of interruption or discontinuation of supply
Q&A Obligation to inform in case of interruption or discontinuation of supply
health.ec.europa.eu
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