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EC Releases Document On Device Shortage Reporting Obligations

 
• By Amanda Maxwell

Device supply interruptions and withdrawals, now common in the EU, could threaten patient safety. Newly issued manufacturer guidance from the European Commission is intended to improve transparency and minimize disruption.

Illuminated sign that reads "Out of Stock."
(Maridav/Shutterstock)

The European Commission has issued a 12-page Q&A document on the new article 10A of the Medical Device Regulation and IVD Regulation which obliges manufacturers to provide information about any anticipated interruption or discontinuation of device supply. The provision will apply from 10 January 2025.

These measures are recognized as critical to head off problems that can arise for physicians and patients where a device is suddenly no longer available, or in short supply.

Device Shortages

Article 10 of the MDR covers general obligations of manufacturers. The new Article 10A of the MDR states:

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