Manufacturers are obliged beginning from 10th January 2025 to notify authorities in case of discontinuation or interruption of supply of certain medical devices.
Which devices?
All models or types of devices, placed on the Union market and for which it is reasonably foreseeable that a supply interruption or discontinuation could result in serious harm or a risk of serious harm to patients or public health in one or more Member States. The manufacturer must determine whether it is reasonably foreseeable that an interruption or discontinuation of their device could result in serious harm or a risk of serious harm to patients or public health.
How?
Manufacturer Information Form on interruption or discontinuation of supply of certain medical devices and certain in vitro diagnostic medical devices (as per Article 10a of Regulation (EU) 2024/1860 amending Regulation (EU) 2017/745 and Regulation (EU) 2017/746).
Provided form to download here: https://health.ec.europa.eu/document/download/919061d9-5dfa-4d0b-ab9b-3543eed98f76_en?filename=md_mdc-2024-16_en.pdf
Get in touch with us if you have questions: info@eumediq.eu.