Medical product availability and healthcare safety are becoming increasingly important talking points in recent years. This is also reflected in the EU regulations on medical devices – starting from 10 January 2025, new reporting obligations regarding interruptions and discontinuation of supply apply for manufacturers. Although the provisions may seem quite straightforward at first glance, their vagueness may give rise to significant doubts as to which situations they will actually apply to in practice.
General framework
According to Article 10a of Regulations (EU) 2017/745 on medical devices (MDR) and (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), where a manufacturer anticipates an interruption or a discontinuation of the supply of a device (other than a custom-made device), and where it is reasonably foreseeable that this could result in serious harm (or a risk of serious harm) to patients or public health, the manufacturer should inform the competent authority, as well as entities to whom it directly supplies the device.
This should be done at least six months before the anticipated interruption or discontinuation, unless there are exceptional circumstances. The information is then forwarded, without undue delay, by the competent authority to other Member States and the Commission, and by the economic operators downstream, down to health institutions and healthcare professionals.
The idea is clear – to enable the authorities and health institutions to consider mitigating measures in the light of upcoming supply interruptions, thereby ensuring patient health and safety. From a manufacturer’s perspective, however, some significant doubts arise as to when exactly and how to report the upcoming supply interruptions and discontinuations. Let’s try to answer some of these key questions.
Who should report?
The reporting obligation is addressed first and foremost to manufacturers of medical devices, irrespective of whether they are EU or non-EU entities. The manufacturer cannot transfer its legal responsibility for this task, although it is admissible for the manufacturer to delegate the execution of the obligation to its authorised representative or other third party (with liability remaining with the manufacturer).
The role of other economic operators is subsidiary – once they receive the information on an upcoming interruption or discontinuation, they are required to pass this information on to their direct contractors without undue delay.
All medical devices are potentially within the scope of Article 10a, including legacy devices under transitional period (certified under the ‘old’ directives), with the exception of custom-made devices.
In practice, the obligation applies mainly to critical devices with a strong market position, especially in cases where there are no alternative solutions.
What is an interruption or a discontinuation?
An interruption occurs when the manufacturer cannot or is unwilling to operate as previously intended or planned, while discontinuation occurs when the device is no longer placed on the market.
The reporting obligation is not limited to any particular reasons for the interruption or discontinuation. Potential cases include regulatory issues (eg difficulties or delays in acquiring new certificates), manufacturing problems, interruptions in the supply chain (eg issues on the component suppliers’ end) or business reasons.
With regard to interruptions, it is worth noting that the Commission’s Q&As provide an important guideline, stating that, in principle, the reporting obligation applies only in situations where the interruption is expected to last over 60 days. It is reasonable to assume, however, that in certain critical situations manufacturers should report even if the predicted term is shorter, but may cause issues for patients or healthcare entities – a risk-based approach is recommended.
As a rule, manufacturers should consider circumstances relating to their manufacturing process, eg including availability of the components, but generally not take into account the subsequent availability of the device by other economic operators or the capabilities of other manufacturers to produce alternative devices.
When to report
As per Article 10a, the information on the anticipated interruption or discontinuation should be provided at least six months beforehand. In light of the guideline, the idea is for the manufacturer to report the upcoming difficulties as soon as possible (even earlier than six months), if it believes that serious harm is reasonably foreseeable.
This six-month deadline does not concern situations where the interruption or discontinuation is caused by unexpected circumstances. In such cases, manufacturers should report as soon as possible, upon learning of these exceptional circumstances.
What should be reported – serious harm (risk)
Although Article 10a of MDR/IVDR is worded in a broad manner the key issue in deciding whether to report should be whether it is 'reasonably foreseeable' that the interruption or discontinuation could result in serious harm or a risk of serious harm to patients or public health. In practice, this should significantly limit the scope of application of the discussed obligation.
Unfortunately, the provision does not provide us with any details about how to understand the 'serious harm' premise. Based on the available guidelines, the following practical advice can be given:
- 'Serious harm' should be assessed by the manufacturer, based on its reasonable knowledge and expectations. Manufacturers are encouraged to consult with health institutions and healthcare professionals, although there is generally no need to conduct extensive market analysis, especially with regard to third-party products.
- Serious harm (or risk thereof) should be deemed to exist where the interruption or discontinuation is likely to cause unavailability of diagnosis method or therapy to a larger group of patients, resulting in the risk of serious injury, imminent risk of death, serious deterioration of patient health, or a life-threatening condition.
- This should particularly be the case if no alternative solutions are readily available. Even where alternatives exist, but require extensive measures (such as additional installations, infrastructure, or significant staff trainings), manufacturers should lean towards reporting
- By contrast, there should be no obligation to report if the manufacturer (or other economic operators) has sufficient stock to bridge the interruption (ie can still serve the demand) or if a suitable successor or alternative device can be supplied.
- The guidelines suggest that manufacturers may often rely on information and risk assessment provided by health entities and healthcare professionals.
Key takeaways
Although the legislative framework is formulated in broad terms, in practice the reporting obligation should apply mainly in the following cases:
- manufacturers of critical (eg life-sustaining or life-saving) devices
- devices with significant market share
- cases where alternative solutions are not readily available
- cases where the manufacturer cannot effectively limit the impact of the anticipated interruptions or discontinuation.
Nevertheless, these are precisely the cases where the public health interest and the patients’ interest are of greatest importance. Thus, it is critical to ensure the rules under Article 10a are followed in such situations.
