Regulation (EU) 2024/1860: Extension of IVDR Transitional Period and New Provisions
Overview: Regulation (EU) 2024/1860 Key Takeaways
Regulation (EU) 2024/1860 amends Regulations (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR) to safeguard the continuous supply of in vitro diagnostic devices across the European Union. Officially published in the Official Journal of the European Union (OJEU), this legislation extends compliance deadlines for legacy IVD devices, introduces mandatory supply disruption declarations for manufacturers and economic operators, and mandates a phased rollout for EUDAMED (the European database on medical devices).
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Extension of IVDR Transitional Period
The publication of Regulation (EU) 2024/1860 in the Official Journal of the European Union (OJEU) marks a crucial legislative update amending Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). The primary goal of this amending regulation is to ensure the uninterrupted continuity of supply for in vitro diagnostic medical devices across the European healthcare market.
This legislation revises key regulatory provisions concerning the mandatory use of EUDAMED (the European database on medical devices) for devices compliant with the regulations, as well as those placed on the market as legacy medical devices under previous directives. In addition, the regulation establishes a new obligation for manufacturers and all economic operators in the supply chain to formally declare any supply disruptions or potential risks of shortages that could impact public health.
Key Provisions of Regulation (EU) 2024/1860
1. Mandatory Reporting of Supply Interruptions
Manufacturers are now required to notify relevant national competent authorities and healthcare providers in advance of any anticipated interruptions or discontinuations in device supply that could potentially impact patient safety or care continuity.
2. Extended Transitional Periods for IVDs
To address administrative bottlenecks, delays in the EUDAMED clinical investigation module development, and limited capacity among designated notified bodies, the extension of IVDR transitional period deadlines was enacted. This additional transition timeline helps prevent critical shortages of essential in vitro diagnostic medical devices throughout Europe. Manufacturers looking to maintain market access should evaluate their pathway to achieve EU MDR compliance for legacy devices and follow structured steps on how to bring legacy devices into IVDR compliance.
3. Phased Rollout of EUDAMED
The EUDAMED database (European database on medical devices) will be implemented in gradual stages as its respective electronic modules become fully operational. This phased implementation minimizes operational disruptions for medical device manufacturers, economic operators, and designated notified bodies while advancing transparent device registration across the EU. Understanding what notified bodies look for in EU MDR technical documentation remains essential during this transitional period.
Navigating Regulation (EU) 2024/1860 with Operon Strategist
Operon Strategist provides end-to-end consulting support to assist manufacturers in adapting to the regulatory updates introduced by the European Commission under Regulation (EU) 2024/1860:
Legacy Device Compliance Support: Delivering comprehensive regulatory roadmaps to help manufacturers meet extended compliance deadlines for legacy IVD devices under updated IVDR requirements.
EUDAMED Implementation Guidance: Directing teams through the phased rollout of the European database on medical devices (EUDAMED) and module-specific data submission requirements.
Notified Body Application Management: Assisting manufacturers in applying to designated notified bodies, securing necessary formal agreements early, and coordinating timely compliance file submissions.
Supply Disruption Notification Execution: Structuring internal procedures and communication strategies to satisfy mandatory supply interruption reporting requirements and communicate effectively with competent authorities.
Uninterrupted EU Market Access: Partnering with medical device organizations to maintain full compliance, minimize market risk, and preserve device availability across the European Union.
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FAQ's
What is Regulation (EU) 2024/1860?
It is an amending regulation published in the Official Journal of the EU that extends IVDR transition timelines, modifies EUDAMED implementation rules, and mandates supply disruption reporting.
Why was the extension of the IVDR transitional period introduced?
The extension addresses limited notified body capacity and delays in EUDAMED development, preventing shortages of critical in vitro diagnostic devices in Europe.
Who is required to report supply disruptions under Regulation (EU) 2024/1860?
Manufacturers and economic operators in the supply chain must report anticipated supply interruptions or discontinuations that could affect patient safety to competent authorities and healthcare providers.
How will EUDAMED be rolled out under the new regulation?
EUDAMED modules will be introduced gradually in phases as each individual electronic system becomes fully functional.
Does Regulation (EU) 2024/1860 apply to legacy devices?
Yes, it updates transitional provisions and EUDAMED reporting rules specifically for compliant devices and legacy IVD devices previously placed on the market under former directives.