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?
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?