Effective from January 10, 2025, medical device and in vitro diagnostic (IVD) manufacturers operating within the European Union must comply with new regulatory obligations to ensure the continuity of medical device supply. The introduction of Regulation (EU) 2024/1860 establishes mandatory advance notification requirements for manufacturers planning to discontinue or interrupt the supply of medical devices and IVDs to the EU market.
This regulatory update represents a proactive measure by the European Commission to address potential device shortages and strengthen healthcare supply chain resilience. This article outlines the core provisions of the new regulation, its implications for manufacturers and distributors, and the required compliance actions.
Looking For a Medical Device Regulatory Consultant?
Let’s have a word about your next project
Overview of Regulation (EU) 2024/1860
Published in the Official Journal of the European Union on June 20, 2024, Regulation (EU) 2024/1860 amends existing frameworks under:
- Regulation (EU) 2017/745 (MDR) — Medical Devices
- Regulation (EU) 2017/746 (IVDR) — In Vitro Diagnostic Medical Devices
Its primary objective is to strengthen the security of medical device supply by ensuring that relevant authorities and healthcare providers are given adequate advance notice in the event of supply disruptions or planned product discontinuations.
What’s New Under Regulation (EU) 2024/1860
The regulation introduces several important new provisions specifically designed to improve medical device supply chain management across the European Union:
Mandatory Six-Month Advance Notification
For the first time, manufacturers must provide a minimum of six months’ written notice before any:
- Discontinuation of a medical device or IVD from the market
- Interruption in the supply of medical devices or IVDs within the EU
This advance notice is mandatory and intended to enable healthcare authorities and institutions to prepare for potential supply gaps.
Required Notification Content
The regulation defines what manufacturers must include in any notification regarding medical device supply disruptions:
- A clear justification for the planned discontinuation or supply interruption
- The intended effective date of discontinuation or supply interruption
- The current stock situation and availability of the affected device
- Details of any alternative medical devices or IVDs that could replace the discontinued product
This level of transparency will enable early decision-making by healthcare authorities and distributors.
Formal Notification Obligations to Stakeholders
Manufacturers are now obligated to notify multiple parties when a medical device supply disruption or discontinuation is planned, including:
- Competent authorities in each Member State where the product is supplied
- Healthcare institutions and hospitals relying on the device
- Distributors and economic operators involved in the product’s EU supply chain
This measure ensures all relevant stakeholders receive adequate notice and can initiate appropriate contingency plans.
Emphasis on Supply Continuity Management
Where appropriate, manufacturers are expected to collaborate with healthcare providers and distributors to implement measures that will maintain medical device supply continuity. This could involve:
- Stockpiling of critical devices
- Accelerating qualification or approval of substitute products
- Adjusting production schedules or logistics operations to minimize disruptions
Why These New Rules Matter for Medical Device Supply
The COVID-19 pandemic exposed significant vulnerabilities in healthcare supply chains, resulting in device shortages that impacted patient care. The new regulation represents a strategic initiative by the European Union to:
- Prevent unexpected shortages of essential medical devices and IVDs
- Enhance the EU healthcare sector’s resilience during market disruptions or public health emergencies
- Strengthen oversight and preparedness within the medical device industry.
These new provisions position manufacturers as key partners in safeguarding the EU’s healthcare infrastructure.
Who Must Comply with Regulation (EU) 2024/1860?
The new regulation applies to all entities responsible for the manufacture and distribution of medical devices and IVDs within the EU, including:
- Manufacturers of medical devices and in vitro diagnostics
- Authorized representatives for non-EU manufacturers
- Importers and distributors involved in medical device supply
- Healthcare institutions that depend on continuous device availability
Each of these parties must review and update their compliance processes and supply chain management systems to reflect the new requirements.
When Does the Regulation Take Effect?
The provisions of Regulation (EU) 2024/1860 will be enforceable starting January 10, 2025.
Medical device manufacturers and distributors are strongly encouraged to prepare now by reviewing internal policies and supply chain risk management frameworks to avoid regulatory breaches and safeguard business continuity.
How to Prepare for Compliance
To meet the requirements of Regulation (EU) 2024/1860, organizations operating in the medical device supply sector should:
- Review and revise their supply chain risk management plans
- Implement formal notification procedures and documentation templates
- Identify critical devices vulnerable to potential disruptions
- Establish transparent and reliable communication channels with authorities and distributors
- Integrate these new obligations into existing quality management systems (QMS) aligned with EU MDR and IVDR standards
Engaging with a specialized regulatory affairs consulting firm can significantly ease the compliance process and ensure readiness ahead of the regulation’s implementation date.
How Operon Strategist Supports Your Medical Device Supply Compliance
Operon Strategist helps medical device and IVD manufacturers meet the new obligations under Regulation (EU) 2024/1860. Our regulatory experts assist in:
- Preparing advance notification documentation
- Reviewing medical device supply risk and continuity plans
- Integrating new requirements into your QMS and EU compliance framework
- Coordinating stakeholder communications to manage supply disruptions
With our expertise in EU MDR, IVDR, and supply chain regulations, we ensure your business remains compliant, market-ready, and operationally resilient.
