EU Regulation 2024/1860 and Device Shortages
What EU Regulation 2024/1860 means for medical device availability and what manufacturers and economic operators should know.
EU Regulation 2024/1860 and ANSM 🇫🇷
I don't have a favourite Competent Authority (no bias here), but ANSM are definitely moving up the ladder with this...
As a result of EU Regulation 2024/1860, Manufacturers must inform the ANSM when the unavailability of the MDs or IVDMDs that they manufacture and/or place on the market, linked to a shortage, a risk of shortage, or a marketing stoppage, may create a risk situation in the management of the patient's state of health.
From 1st September 2024, ANSM are implementing a new procedure for device shortages which covers two elements - temporary breaks and marketing discontinuations. ANSM have developed flowcharts specifically for temporary breaks as well a risk analysis grid to aid manufacturers define what is required to be reported or not. They have also published some associated guidance documents, all of this information can be implemented by manufacturers into their QMS in order to determine when they need to report, and how to do so.
Judith de Wilde wrote a great document on manufacturers readying their QMS with these new requirements a few weeks ago. These documents and the guidance by ANSM can hopefully add to that great piece of work.
Here a link to the original post - https://lnkd.in/eEArZF2q
Here is the link to the ANSM page, which contains all of the documents mentioned above - https://lnkd.in/e-SsWrxq
Really cool bit of work here by ANSM and great to see.
If you need any assistance with medical device regulatory consulting, get in touch.
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