EU Medical Device Class I - Stability (Shelf Life) Test

J

jan.stepanek

#1
Dear All, I would like to ask if it is always necessary to make a stability (shelf-life) tests for a medical devices class I within EU regulation? Or in which cases it is not necessary. I cannot find a specific answer for this. Thanks for Help. Jan
 
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M

MIREGMGR

#2
If you make a claim of some particular effective life, or if you have information regarding the device having a limited life, you must have a basis for the effective life you claim, or are required to offer, or that end users are led by your marketing and their reasonable understandings to expect.

That could be testing of a new product or of an existing product with a new process or material, or it could be based on market experience for an unchanged existing product.

In some cases it may be possible to make a reliable engineering inference if your product is very similar to another already-marketed product for which effective life data is available.
 
J

jan.stepanek

#3
Thanks - I have the same opinion about it. I only wanted to ask if there is some strict rule about stability tests for MD Class I. So this will be on evaluation from our side how you wrote. Thanks.
 
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