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Commission admits to potential device shortages because of MDR

  • Posted by: inetika
  • Category: GLOBAL NEWS

A new Commission ‘Factsheet for healthcare professionals and health institutions’ acknowledges there may be supply chain problems during the MDR transition, stating the potential for some devices to “become temporarily unavailable.”

The full extract from the Factsheet reads:

“These changes could have consequences for the availability of medical devices for health institutions. For instance, manufacturers may choose to stop the production of certain medical devices. Furthermore, if certain medical devices do not get their certificates on time these products may become temporarily unavailable. Ask your suppliers to inform you in good time about the availability of the devices you need.”

This is not how a smooth transition from one regulatory regime to another should be managed.

The factsheet also includes a ‘Checklist for preparedness of healthcare institutions’, covering:

  • Traceability
  • In-house devices / health institution exemption
  • Reprocessing of single-use devices
  • Clinical investigations / performance studies
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