Class I non-sterile "Shelf Life" labeling (EU/UK)

Edward Reesor

Trusted Information Resource
Greetings all, I require your sage wisdom and direction.

We have a Class I non-sterile medical device with defined "Shelf Life X Years". The time frame has been validated and its more of a best before life than anything. The label includes Lot# and date of manufacture with "Shelf Life X Years" clearly stated on the label and IFU. What I am looking for is the reference that states the date of expiration is mandated in proper format and symbol.

Thank you in advance
 

ngala

Registered
Do we need to perform shelf life testing for class 1 non sterile medical products per EU MDR? Or can we provide sufficient justification? The products have shelf life mentioned on label. I couldn't find sufficient information for non sterile products. Also, accelerated testing has been performed. Do we need real time aging test or accelerated anyways? Please could you also point down where to find the information regarding same? Your help is much appreciated.
 
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planB

Super Moderator
In case product characteristics may be prone to non-acceptable change over time, such as potential degradation, you may want to define and substantiate a shelf life. Otherwise not. Accelerated-aging studies may be performed in order to reduce time-to-market. Typically, real-time aging studies may be initiated in parallel, in order to substantiate the model/assumptions accelerated-aging studies inherently contain. These are concepts typically applied to sterile-barrier systems, and you could transpose these concepts from ISO 11607-1:2019.
 
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