Below we present you with a summary based on the newly published Q&A document prepared by the European Commission, which addresses the practical aspects of fulfilling the manufacturer's new obligation to inform about the interruption or termination of supply of certain medical devices. This obligation is set out in Article 10a of the MDR and IVDR, which is being implemented by the amending Regulation (EU) 2024/1860 of 13. 6. 2024 amending the MDR and IVDR as regards a gradual roll-out of Eudamed, the obligation to inform in case of interruption or discontinuation of supply, and transitional provisions for certain in vitro diagnostic medical devices.
Article 10a of the MDR and IVDR, effective from 10. 1. 2025, introduces a new obligation for medical device manufacturers to inform of interruptions or discontinuation of supply of their medical devices. From this date, manufacturers of medical devices will be required to inform about interruptions or discontinuation of supply of their medical devices that have occurred or are due to occur from this date. The obligation to report information on interruptions or discontinuation of supply will apply to all manufacturers situated inside or outside the EU.
The manufacturer's obligation in article 10a applies to all medical devices which have been placed on the EU market and for which it can reasonably be foreseen that an interruption or discontinuation of supply could result in serious harm or risk of serious harm to patients or public health in one or more member states. This obligation also applies to legacy devices, which are devices placed on the market before the adoption of the MDR and IVDR regulations but are still legally marketed and supplied in accordance with the transitional provisions of these regulations. In contrast, custom-made devices, i.e. devices that are manufactured on prescription for specific patients and respond to their individual medical condition and needs, are exempted from this obligation.
The manufacturer will be obliged to inform economic operators (importers and distributors), medical establishments (hospitals) and health professionals, to whom they directly supply their medical devices and who are affected by the interruption or discontinuation of supply.
Information on the interruption or discontinuation of supply should be provided by the manufacturer at least six months before such expected interruption or cessation of supply. However, there are situations where it will be difficult or impossible to meet the six-month deadline. These situations are referred to as exceptional circumstances. In such cases, the manufacturer should inform its customers without undue delay.
Author: Alžběta Frýdlová