EC: Q&A Information on Interruption or Discontinuation of Supply of Medical Devices
The European Commission has published a Q&A 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 (MDR) and (EU) 2017/746 (IVDR).
This Q&A document is intended to facilitate the application of the above mentioned regulations 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.
Summary of the Q&As:
- Implementation Date: Article 10a obligations begin January 10, 2025. Interruptions anticipated before this date do not require reporting but may be voluntarily shared.
- Scope of Obligation: Manufacturers, including those outside the EU, must inform relevant parties about anticipated supply interruptions. This applies to all devices (excluding custom-made devices) if supply issues could cause harm to patients or public health.
- Obliged Parties to Inform: Manufacturers are required to notify economic operators, competent authorities, and healthcare institutions or professionals they directly supply. Economic operators must ensure that this information is passed further downstream without alteration.
- Timing of Notification: Typically, manufacturers must notify at least six months before an anticipated supply interruption unless unforeseen circumstances prevent this.
- Exceptional Circumstances: Unexpected events like natural disasters, raw material shortages, or financial challenges may allow manufacturers to notify with less than six months’ notice.
- Defining Supply Interruptions: An interruption of supply should be understood as having a temporary inability to place individual devices of a given model or type on the Union market, with an expected duration of more than 60 days, as a general indication.
- Reasons for Interruption: Manufacturers must specify reasons, which could include regulatory, manufacturing, supply chain, or business-related causes.
- Risk of Serious Harm: Manufacturers must assess whether an interruption could cause serious harm, such as health risks or treatment delays, based on the device’s role and patient impact.
- Data Confidentiality: Information provided to competent authorities is governed by MDR/IVDR confidentiality rules, although authorities may need to share details with healthcare entities.
- Information Submission:I Notifications should be submitted using the forthcoming Manufacturer Information Form, and countries may provide specific submission instructions.
- Responsibilities of Economic Operators: Economic operators who receive notification must share it promptly and unchanged with other relevant entities, such as healthcare institutions, to allow timely planning.
- Application to System Packs: For devices used within system or procedure packs, manufacturers must inform relevant parties in the supply chain, who must then notify healthcare providers.
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