The Federal Institute for Drugs and Medical Devices (BfArM), the German regulating authority in the sphere of healthcare products, has published a notice dedicated to notifications of interruptions or terminations of the supply of medical devices the parties responsible should submit in order to communicate the crucial information to all the stakeholders involved. The document highlights the key points to be taken into consideration in order to ensure compliance with the applicable regulatory requirements and also provides additional clarifications and recommendations.
Table of content
Introduction
With effect from January 10, 2025, manufacturers of medical devices will be required to comply with new notification requirements under Article 10a of Regulation (EU) 2017/745 and Regulation (EU) 2017/746. This regulation establishes that any interruption or termination of the supply of a medical device must be reported if it poses a serious risk to patient safety or public health within the European Union.
The primary objective of this regulatory update is to ensure that healthcare institutions and relevant authorities receive timely and comprehensive information, allowing them to take necessary measures to safeguard patient care and mitigate any potential disruptions.
Objectives of the MDR/IVDR Amendment
Regulation (EU) 2024/1860 introduces critical amendments to the MDR and IVDR, focusing on three key objectives. First of all, it aims to maintain a high level of patient safety and public health protection by mitigating the risks associated with supply interruptions of medical devices and in vitro diagnostic devices (IVDs).
Ensuring the continued availability of these essential healthcare products is crucial for the smooth functioning of medical services. To facilitate this, the regulation provides manufacturers and notified bodies with additional time to complete the necessary conformity assessments under the IVDR framework.
Secondly, the regulation requires manufacturers to notify relevant authorities and stakeholders before discontinuing or interrupting the supply of medical devices. If a manufacturer does not directly supply healthcare institutions, this responsibility extends to economic operators in the supply chain.
This cascading flow of information ensures that all relevant entities, including healthcare institutions and professionals, are well-informed and can prepare accordingly to minimize the impact on patient care. The third major aspect of the amendment is the gradual implementation of Eudamed, the European medical device database.
Instead of delaying the mandatory use of Eudamed until all six modules are completed, the regulation permits a phased rollout of the completed modules. This approach enhances market transparency and provides regulatory bodies with essential data regarding the availability and compliance of medical devices within the European Union.
Obligations of Medical Device Manufacturers
The new requirements set forth under Article 10a of the MDR/IVDR became applicable on January 10, 2025. Manufacturers anticipating supply interruptions or discontinuations before this date are not required to submit notifications, even if the actual disruption extends beyond the effective date.
However, to promote best practices, manufacturers are encouraged to voluntarily notify relevant stakeholders in advance. These notification requirements apply to all medical devices and IVDs, with the exception of custom-made devices.
The regulation also includes legacy devices covered under MDR Article 120(13) and IVDR Article 110(11). Manufacturers must assess whether a foreseeable supply disruption could lead to serious harm or a risk to patient health.
If such a risk is identified, they are obliged to comply with the reporting requirements outlined in the regulation.
Notification Requirements
In accordance with the applicable regulations, manufacturers must notify multiple stakeholders when anticipating an interruption or termination of supply. The competent authorities of the Member State where the manufacturer or its authorized representative is established must be informed, ensuring regulatory oversight.
Additionally, manufacturers are required to notify economic operators, healthcare institutions, and healthcare professionals to whom they directly supply the device. This approach is intended to ensure that all affected parties receive timely information and can make informed decisions regarding patient care and medical device procurement.
To provide stakeholders with sufficient time to prepare for any supply disruptions, manufacturers are required to issue notifications at least six months in advance. In exceptional cases, where an unforeseen event prevents timely notification – such as a sudden shortage of raw materials or an unexpected regulatory issue – manufacturers must report the disruption as soon as possible, without undue delay.
The notification must include detailed information regarding the reason for the interruption or discontinuation. This could encompass regulatory issues, manufacturing challenges, supply chain disruptions, or business-related decisions.
Furthermore, manufacturers are required to assess the potential risks posed by the disruption and determine whether alternative solutions exist. If suitable alternative devices or treatment methods are available, these should be communicated to the affected stakeholders.
The impact on healthcare services must also be considered, with manufacturers providing insight into how the disruption may affect patient care and medical service delivery. In Germany, the notification process is centralized through the BfArM.
Notifications must be submitted electronically using the European Commission’s standardized reporting format, ensuring that all data is machine-readable and easily accessible to regulatory bodies.
Obligations of Other Economic Operators
Economic operators within the medical device supply chain, such as importers and distributors, also bear responsibility for disseminating information regarding supply disruptions. Once they receive a notification from the manufacturer, they are required to relay this information to relevant healthcare institutions and professionals without modification.
This ensures that all affected parties receive accurate and consistent information, preserving the integrity of the communication process. For example, if a manufacturer of CE-marked pacemakers anticipates an interruption in supply starting on December 1, 2025, they must notify the relevant competent authority and their direct importers by June 1, 2025.
Upon receiving this notification, importers must promptly inform all distributors within their network, who in turn must ensure that healthcare institutions and professionals receive the necessary information in a timely manner. This structured information flow allows for proactive planning and risk mitigation by all involved stakeholders.
Definition and Assessment of “Serious Harm”
A key aspect of the notification requirement is determining whether a supply disruption could lead to serious harm to patients or public health. Serious harm is defined as any situation where patient health is significantly compromised due to the unavailability of a particular medical device.
This could include imminent risks of severe deterioration of health conditions, or the inability to perform life-saving treatments due to the absence of a critical medical device. Manufacturers are responsible for conducting a thorough risk assessment to determine the impact of a supply interruption.
This assessment should consider factors such as the device’s role in essential healthcare services, its availability in the market, and the existence of alternative solutions. Manufacturers may consult with healthcare professionals, medical societies, and healthcare institutions to gain further insight into the potential impact of their supply disruptions.
Regulatory Compliance and Confidentiality
Under Articles 109 MDR and 102 IVDR, competent authorities are responsible for sharing relevant supply interruption information with other Member States and the European Commission. However, sensitive business information provided by manufacturers remains protected under confidentiality provisions.
To ensure compliance, manufacturers must submit notifications using the Manufacturer Information Form (MIF), as specified in MDCG 2024-16. If any updates or modifications to the submitted information are necessary, manufacturers must clearly indicate these changes when resubmitting the form.
Member States may provide additional guidance on the specific procedures for submission.
Conclusion
In summary, the introduction of Article 10a under MDR/IVDR represents a significant step towards enhancing regulatory oversight and ensuring the continuity of medical device availability within the European Union. The mandatory six-month notification period provides ample time for stakeholders to prepare for potential disruptions, while exceptions allow flexibility in unforeseen circumstances.
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