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Requirement to Conduct New Shelf-life Testing? (re-do testing for design change)

S

Sammy23

Starting to get Involved
#1
#1
Hi,

Does the MDR specify that we MUST re-do aging/stability testing if there is a design change? If the design changes, for example the material used for the device is now different and certain specifications are changed to meet newly noted market demand, do we need to re-do aging? Or does some rationalization exist or some guidance document to say its fine to not re-do aging? I'm looking for anything in the MDR and FDA guidance documents?
 
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shimonv

shimonv

Trusted Information Resource
#2
#2
The MDR is a law that is intended to cover ALL medical devices in Europe. It does not have absolute statements like the one you are asking about.
Every product design or design change is unique. You need to evaluate the impact of the change on the shelf-life and the service life of the device.
The evaluation should be part of the engineering changer order process, with engineering rationale and link to risk management and V&V files.
 
Ed Panek

Ed Panek

QA RA Small Med Dev Company
Trusted Information Resource
#3
#3
FDA requires any shelf life changes to use the same evaluation methods as in your original submission for approval 510(k). Accelerated aging is ok but must be followed up with real-time aged sample testing.
 
S

Sammy23

Starting to get Involved
#4
#4
shimonv said:
The MDR is a law that is intended to cover ALL medical devices in Europe. It does not have absolute statements like the one you are asking about.
Every product design or design change is unique. You need to evaluate the impact of the change on the shelf-life and the service life of the device.
The evaluation should be part of the engineering changer order process, with engineering rationale and link to risk management and V&V files.
Click to expand...
That makes sense. Thank you! I'll refer to the change assessment guidance.
 
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