What it's All About
Under Regulation (EU) 2024/1860, the European Commission has amended Article 10a of the EU MDR and expanded the requirements for manufacturers of medical devices in the area of supply chain and supply security. The amendments came into force on 10 January 2025 and relate in particular to the obligation to report impending or actual supply disruptions.
In a question-and-answer document (Q&A paper), the Commission is now setting out for the first time how the new obligations are to be implemented in practice.
In this three-part series of articles, we summarise the key requirements of the Q&A paper. The first part deals with the early identification of potential bottlenecks and the structured assessment of associated risks. The second part focuses on robust communication chains, whilst the third part covers active mitigation and contingency strategies.
Resilience in a Complex World
The Commission’s stance is clear: Manufacturers should not be caught unprepared by supply disruptions, but should identify, assess and manage potential risks at an early stage; for in medical technology in particular, supply disruptions can have a significant impact on patient care and the stability of healthcare systems.
Point 1: Early Detection and Structured Case Assessment
Manufacturers should identify bottlenecks before they occur.
Clearly, if a product can no longer be manufactured, it is obvious to everyone that there is a supply shortage.
The Commission requires manufacturers to anticipate any interruption in the supply of a device, particularly if this interruption is expected to last longer than 60 days. However, the 60-day period is merely a guideline. It is important that manufacturers adequately assess the consequences for patients or user care, are able to document and justify their assessment, and notify the relevant authorities and customers in the event of a potentially dangerous supply disruption.
It is irrelevant whether a product is unavailable due to disrupted supply chains or whether the supply interruption is a deliberate decision by the manufacturer.
The notification requirement also applies to all cases in which a manufacturer is no longer able or willing to produce or supply a product in the quantities previously supplied. The measure is therefore not based on static initial conditions, but should be applied in a context-specific and dynamic manner.
To be on the safe side, manufacturers should always ask:
Will a change in the production, delivery or availability of Product X result in a significant adverse impact on users or distribution partners – and have I adequately monitored and assessed this through continuous monitoring, reliable verification and structured risk assessment?
The following criteria must be demonstrably met:
- continuous monitoring of supply and production chains,
- defined criteria for assessing potential supply disruptions,
- decision matrices structured on the basis of these criteria,
- clear lines of responsibility within the company,
- clear lines of responsibility and defined escalation procedures.
At Your Side
The requirements of Article 10a of the EU MDR make it clear that manufacturers must not only identify potential supply disruptions, but also be able to document their assessments in a robust manner and justify them from a regulatory perspective.
Are you unsure whether your monitoring, evaluation and escalation processes meet the European Commission’s expectations? BEO BERLIN supports medical device manufacturers in establishing transparent vigilance and risk assessment systems in line with the regulatory requirements of the EU MDR.
This is Part 1: Surveillance.
Click here for Part 2: Communication (available online from 21 May 2026).
And here is Part 3: Countermeasures (online from 27 May 2026).
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