By Robert J. Kerwin

Effective January 10, 2025, manufacturers doing business in the European Union must inform under a new amendment to the EU MDR (Article 10a) the relevant competent authorities and “economic operators” if an interruption or discontinuation of medical devices is “reasonably foreseeable” to result in serious harm or a risk of serious harm to patients or the public health.

If manufacturers are directly supplying medical devices to health institutions or professionals, they must inform them of the interruption or discontinuance, (they are not required to inform those who they do not directly supply).

Once the manufacturer notifies under this provision, the sharing of this information is expected in the downstream supply chain to the “economic operators.” Under the EU MDR “economic operators” include authorized representatives, importers, distributors or persons that are part of the supply chain.

Accordingly, by the broad definition of economic operators, independent sellers and servicers in the EU will be required to inform their customers — health institutions or professionals — when they learn of interruptions or disruptions in the medical device supply chain.

While the impetus for this regulation may certainly be traced to governmental concerns during the pandemic as to supply chains, other governmental authorities have implemented similar laws and regulations requiring notification. The U.S. Food, Drug and Cosmetic Act was amended (Section 506J) to require manufacturers of a medical device to notify the FDA of a permanent discontinuance or interruption likely to lead to a meaningful disruption in the domestic supply of that device.

No exact definition of "interruption" has been provided, though it has been suggested that a temporary inability to place a device on the market with an expected duration of more than 45 days, would fall within a general understanding of disruption. It seems it is entirely possible that an interruption of less than 45 days may also have to be disclosed, depending upon the potential for serious harm.

While the regulation language is fairly terse and one could see different national authorities imposing different interpretations of this new regulation, it would seem that heightened demand for a device, alone, would not be a reason that would typically require manufacturer disclosure. Expected root causes for the notifications might include: (i) safety and performance issues; (ii) regulatory issues such as a loss of compliance; (iii) delays in certification of the device; and/or (iv) suspended or withdrawn certificates. It may also be that a natural disaster or shortage of raw materials might precipitate the obligation to notify.

Notices of shortages or discontinuations should be provided under the new Regulation at least six months before the anticipated interruption or discontinuation, except in circumstances where such is not possible. The manufacturer is required to specify the reasons for the interruption or discontinuation to the competent authorities.

The economic operators who receive this information are required “without undue delay” to inform any other economic operators, healthcare institutions and healthcare professionals of the anticipated interruption or discontinuation. Economic operators are already required to achieve an appropriate level of traceability as to the devices they sell, such that they are required to be able to identify those who they supplied.

We expect more information on this new regulation in the form of a guidance in the near term. The EU Medical Device Coordination Group is currently working on a "questions and answers" document to facilitate a better understanding of this regulation.

About the author: Robert Kerwin is general counsel to IAMERS and IAMERS representative to the EU MDCG interest group on Post-Market Surveillance and Vigilance.