EU tightens health tech regulations on supply chain disruptions
Published on 31st Oct 2024
European Commission clarifies new rules for 2025, mandating early notification of potential medical device supply issues
A recent legislative amendment to the Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) has introduced an additional provision to both pieces of legislation.
According to a new article 10a in both regulations, manufacturers are obliged to notify competent authorities and other stakeholders of any anticipated product interruptions or discontinuations that could result in serious harm to patients or public health. A new questions and answers (Q&A) document by the European Commission provides practical guidance on implementing these requirements that will be effective from 10 January 2025.
Products affected
The Q&A document clarifies which devices and in vitro diagnostics (IVDs) are captured by article 10a of the MDR and IVDR.
The provision applies to all models or types of devices, with the exception of custom-made devices, that are placed on the Union market and for which it is reasonably foreseeable that a supply interruption or discontinuation could result in serious harm or risk of serious harm to patients or public health in one or more Member States.
This also includes legacy devices, which were placed on the market under the previous European directives – the Medical Device Directive or Active Implantable Medical Devices Directive for medical devices and In Vitro Diagnostic Medical Device Directive for in vitro diagnostics) – and are still available on the market during the transitional periods provided by the MDR and IVDR.
Compliance timeline
Article 10a of the MDR and IVDR stipulates that manufacturers must inform relevant parties of any anticipated supply interruptions or discontinuations at least six months in advance, except in exceptional circumstances.
Applying the requirement from 10 January 2025 means that any interruptions or discontinuations anticipated before this date do not need to be reported, even if they occur after the effective date. Manufacturers are, however, encouraged to voluntarily inform users of supply issues before this date in line with best practices.
The six-month notification period is designed to give competent authorities, health institutions and other stakeholders sufficient time to implement mitigating measures to ensure patient safety and public health. This proactive approach aims to prevent any potential negative impact on healthcare services due to supply disruptions.
In exceptional circumstances where a manufacturer cannot anticipate or confirm a supply interruption or discontinuation six months in advance, they must inform the relevant parties without undue delay. Such circumstances may include sudden and unexpected events like natural disasters, unforeseen issues in the supply chain or other external factors that directly impact the manufacturing process or supply of the device.
EU guidelines
The Q&A document provides detailed guidance on what constitutes the anticipation of an interruption or discontinuation of supply. An interruption is defined as a temporary inability to place a device on the market for more than 60 days, while a discontinuation refers to a permanent cessation of supply.
Manufacturers must confirm any interruptions or discontinuations based on their own capabilities or information from third parties and assess whether these could result in serious harm to patients or public health.
Manufacturer duties
Manufacturers are required to inform the competent authority of the Member State where they or their authorised representative are established, as well as the economic operators, health institutions and healthcare professionals to whom they directly supply the device.
Manufacturers must also specify the reasons for the interruption or discontinuation in their notifications.
Regulatory reasons for anticipated interruptions or discontinuations may include a loss of compliance with the MDR or IVDR, delays in certification, or decisions not to pursue certification for certain devices. This echoes one of the points made in the recent Draghi report to the European Commission, which confirmed the industry's position that current regulatory challenges heighten the risk of supply disruptions and may result in withdrawal of essential diagnostics or devices from the EU market.
Manufacturing reasons could involve device performance issues or difficulties in obtaining raw materials or components.
Disruptions to the supply chain might be caused by shortages or logistical challenges, while economic or marketing decisions could involve strategic business choices to discontinue certain product lines.
The notification process involves completing a "manufacturer information form" that specifies the details needed for the notification, including the reasons for the interruption or discontinuation and any additional relevant information. Once available, this form will be used to provide the required information to the competent authority.
Distributors and importers
Importers and distributors who receive information about an anticipated supply interruption or discontinuation from the manufacturer must pass this information along the supply chain without undue delay. This ensures that relevant economic operators, health institutions and healthcare professionals are informed in a timely manner.
In addition, all economic operators remain bound by traceability requirements laid down in the MDR and the IVDR, which are essential for ensuring that information about supply interruptions or discontinuations can be accurately and efficiently communicated throughout the supply chain.
Healthcare regulators
Upon receiving a notification from a manufacturer, the competent authority must inform the competent authorities of other Member States and the Commission without undue delay. This facilitates a coordinated response to potential supply issues across the EU. The competent authority may also need to share information with health institutions, healthcare professionals, importers, or distributors within their jurisdiction to ensure patient safety and public health.
The information provided to the competent authority is subject to article 109 of the MDR and article 102 of the IVDR, which govern the confidentiality and protection of information and provide for legal exceptions.
Osborne Clarke comment
Ahead of the January 2025 deadline, manufacturers may find it beneficial to develop robust monitoring and communication processes to anticipate and manage potential supply interruptions or discontinuations. Close relationships with suppliers and stakeholders can help swiftly address emerging issues, meeting the six-month notification requirement and reducing supply risks. Distributors and importers should consider implementing effective traceability systems to ensure timely information sharing. Accurate records and identification of suppliers can facilitate prompt communication of supply interruptions, enabling all parties to take necessary actions.
The upcoming obligations require a proactive approach to maintain the supply of CE-marked devices, both new and legacy ones. Effective monitoring, robust device tracing and careful management of authority interactions can help mitigate supply disruptions and ensure compliance, ultimately supporting patient safety across the EU.
