New EU guidelines for medical device supply continuity – MDR & IVDR

In October 2024, the European Commission introduced a new Q&A guidance document on Article 10a of the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) through Regulation (EU) 2024/1860. This regulation mandates manufacturers to provide early notice to relevant authorities and stakeholders about any anticipated interruptions or discontinuations in the supply of certain medical and in vitro diagnostic devices.

Article 10a obligations under MDR and IVDR

Updated Manufacturer obligations under MDR and IVDR are presented in Regulation (EU) 2024/1860. It has been established a new notification requirement for manufacturers in the event of anticipated supply interruptions or discontinuations. These obligations are aimed at supporting patient safety, maintaining the supply of essential devices, and improving transparency across the healthcare supply chain.

Objective of the MDR/IVDR amendment

The primary objective of the MDR/IVDR amendment is to ensure consistent access to essential medical and in vitro diagnostic devices without compromising quality standards. The amendment prioritizes patient safety through three core measures: continuous supply of critical devices, mandated manufacturer notifications for potential supply disruptions, and a gradual implementation of the Eudamed database to enhance supply chain transparency.

Information obligations in case of supply interruption or discontinuation

The updated regulation introduces specific obligations for manufacturers and economic operators to promptly inform relevant stakeholders in the case of anticipated supply disruptions, ensuring healthcare providers and patients are prepared for any potential impact.

The provisions of Article 10a apply from January 10, 2025, and require all supply interruptions or discontinuations with potential health impacts to be reported. Manufacturers should inform stakeholders of supply interruptions even prior to the effective date, following best practices.

The notification obligation applies to all device types except custom-made devices, and includes products where any supply interruption could reasonably lead to serious risks for patients or public health. These requirements extend to legacy devices as well, under specific conditions.

Manufacturers’ obligations

Manufacturers are required to notify directly supplied economic operators, health institutions, and healthcare professionals, as well as the relevant competent authority in the Member State of their establishment or authorized representation. This allows for a swift response and preparation at all levels of the healthcare supply chain.

Notifications should ideally be made at least six months in advance of a planned interruption or discontinuation. However, exceptional circumstances, such as unexpected natural events or sudden supply chain disruptions, allow for immediate notification without meeting the six-month advance requirement.

Exceptional circumstances include any unanticipated events that hinder a manufacturer’s ability to comply with advance notice requirements. Manufacturers are expected to implement adequate monitoring systems to detect such events and notify stakeholders as soon as possible.

The anticipation of an interruption or discontinuation refers to the manufacturer’s confirmation that a disruption is imminent. This includes the manufacturer’s assessment of its own supply capabilities, potential mitigation strategies, and stakeholder communication plans.

Economic operators’ obligations

Economic operators’ obligations are to cascade information to the next level of the supply chain as soon as it is received. This chain of notification helps ensure that relevant institutions and professionals receive timely information to manage or mitigate potential supply impacts.

Reasons for supply disruption

Manufacturers are required to specify the reason for any anticipated supply interruption in their notifications. These reasons could include regulatory factors, manufacturing issues, supply chain limitations, or business decisions, as well as any external events that impact supply continuity.

Assessing the risk of serious harm to public health

A supply interruption or discontinuation could be classified as a serious risk if it significantly impacts access to critical medical diagnostics or treatments. The absence of key devices in specific medical procedures could lead to severe health risks, especially when no alternatives are available.

Manufacturers are responsible for assessing whether a supply disruption could result in serious harm to the intended patient population. This assessment should take into account available information and consider input from healthcare providers or relevant stakeholders when needed.

Manufacturers should assess certain indicators to evaluate potential risks from supply disruptions. Key indicators include the device’s importance for critical healthcare functions, the availability of alternative solutions, and operational factors such as current market supply levels, the manufacturer’s mitigation measures, and potential stockpiles.

Providing information to Competent Authorities

Manufacturers must use the “Manufacturer Information Form” to notify competent authorities, with submission protocols available on the competent authority’s website. This standardized process ensures authorities receive consistent and complete information, which may be shared with other EU bodies as needed to support healthcare continuity.

Economic operators’ role in the supply chain

Economic operators receiving notification from manufacturers are required to distribute the information throughout the supply chain without delay. This quick and transparent communication enables health institutions and healthcare professionals to prepare for potential device shortages and implement necessary precautions.

Summary

Regulation (EU) 2024/1860 enhances patient safety and supply chain transparency by requiring manufacturers to notify stakeholders of anticipated supply interruptions or discontinuations. By promoting coordinated notification efforts across the healthcare supply chain, this amendment helps protect patient health and ensures that essential medical devices remain accessible across the EU.

This guidance provides a foundation for manufacturers and economic operators to align with the EU’s rigorous standards, reinforcing the integrity and safety of medical device supply in the healthcare system.

Link do the document:

https://health.ec.europa.eu/document/download/b431b10f-8512-4f47-9191-e1b84b2f9a27_en?filename=mdr_qna-article10a_mdr-ivdr_en.pdf