The “new” Art. 10a MDR

The new Article 10a of the Medical Device Regulation (EU) 2017/745 (MDR) has been in force since January 10, 2025. The regulation entails comprehensive information obligations for all economic operators in the medical device sector. The aim of the regulation is to identify potential supply bottlenecks for certain medical devices at an early stage and thus avoid serious consequences for patients and public health.

The key facts are as follows:

In the event of an expected supply shortage, manufacturers of medical devices must check whether they are subject to the information obligations of Art. 10a MDR. These apply if, inter alia, the following conditions are met:

(1)  The manufacturer concludes, on the basis of its own discretionary decision, that a significant interruption or termination of supply is to be expected in relation to a specific product or product group. It is currently assumed that a supply bottleneck is significant if the product is unavailable for more than 60 days.

(2)  The manufacturer's assessment also shows that there are no alternative products or alternative therapies available on the European market for the “discontinued” product.

(3)  The manufacturer's forecast shows that the supply shortage could result in serious harm to patients or public health in at least one of the EU Member States. It is not defined in more detail in the MDR when such “serious harm” must be assumed. In this respect, the American Critical Medical Device List (CMDL) offers initial guidance although is certainly not exhaustive.

If the above requirements are met, manufacturers must inform the national health authorities, economic operators (e.g. importers and distributors) and customers (healthcare facilities, etc.). This information must be provided at least six months before the expected supply bottleneck occurs. The exact scope of the actors to be informed is not specified in Art. 10a MDR. Whether the manufacturer must therefore, for example, only inform its own customers or all potential customers/healthcare facilities remains unclear. Initial explanations and discussions show a tendency to the effect that information towards the manufacturer's own customers should be sufficient.

If, against this background, economic operators are notified by manufacturers, they are in turn obliged to pass on the information to their customers.

What does this new regulation mean for manufacturers of medical devices?

In order to comply with the comprehensive testing and information obligations, manufacturers of potentially critical products should keep the following points in mind: 

• Implementing review and information obligations in internal processes
• Continuous monitoring of production/production planning for critical products (e.g. monitoring possible causes for significant supply bottlenecks/keeping an eye on the supply chain)
• Clarification of distributors' information obligations in distribution contracts (forwarding of manufacturer information)

Meike Kapp-Schwoerer and Francesca Pisacane will be happy to answer any questions you may have.