In response to increasing concerns over supply chain stability and its impact on healthcare delivery, on June 13, 2024 the European Union published Regulation (EU) 2024/1860 of the European Parliament and of the Council which amends both the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) to introduce new obligations for companies facing supply problems and to facilitate the timely roll-out of Eudamed. These regulatory updates are aimed at ensuring the continued availability and safety of medical devices and in vitro diagnostics (IVDs) amid supply disruptions, which have become a critical issue in recent years. These updates come as part of a broader effort to enhance the resilience of the healthcare system and mitigate risks associated with shortages of essential medical products.
The Regulation was applicable from the day it was published in view of the exceptional circumstances arising from the significant delay in the development of the electronic system on clinical investigations and performance studies of Eudamed, noting concerns over expired certificates or those due to expire before May 26, 2025, the ability to provide legal certainty for economic operators and healthcare providers, and for reasons of consistency as regards the amendments to both MDR and IVDR regulations. To provide flexibility in the face of ongoing supply challenges, the regulations include provisions for extending temporary measures that allow continued use of certain medical devices and IVDs that are experiencing supply issues. These extensions are subject to specific conditions and are designed to ensure that patient care is not compromised.
Manufacturers are now required to report any significant supply chain disruptions that could affect the availability of their products leading to the associated risk of a public health crisis. This includes notifying relevant competent authorities or authorized representative about potential shortages, production delays, or issues with raw materials that could impact the supply of medical devices and IVDs or of plans to discontinue product(s). Manufacturers are also required to inform economic operators, health institutions, and healthcare professionals to which directly supply the affected device(s). This obligation to inform is expected to be done at least six months prior to the anticipated interruption or discontinuation, except under exceptional circumstances.
Companies must develop and implement contingency plans to manage supply chain disruptions effectively. These plans should outline strategies for mitigating risks, such as sourcing alternative suppliers, increasing inventory levels, or adjusting production schedules to address potential shortages. Regulatory authorities will have enhanced oversight capabilities to monitor and address supply chain issues more proactively. This includes the authority to request detailed information from manufacturers regarding their supply chains and to impose corrective actions if necessary.
The EU’s updates to the MDR and IVDR reflect a proactive approach to managing supply chain disruptions in the medical device and IVD sectors. By introducing new obligations for reporting, contingency planning, and communication, the regulations aim to enhance supply chain resilience and ensure that critical medical products remain available and safe for patients.
As the healthcare landscape continues to evolve, these regulatory updates represent a crucial step towards safeguarding patient care and maintaining the integrity of the medical device and IVD supply chains in the face of ongoing challenges.
Read the full regulation here.
