I understand the basic premise of revalidating a process when there is a significant change to the process itself or change in material composition that may affect the physical characteristics of the medical device.
But let’s say that a certain type of polymer resin, used for cable extrusion or injection molding, has been discontinued and the supplier provides a substantially equivalent alternative. Is revalidation necessary for a Class II medical device?
Yes, revaldation is necessary for class II medical devices.
The major reason is you are moulding this device with a new resin material similar to the earlier one and its an alternative too.
Secondly any change of primary materials in medical devices a change control, Risk evaluation and Validation.
Validation with 3 lots is necessary and all the tests that are performed on the earlier material must be performed here too.
There are no short cuts here. Here this attracts a major change.
Agrred with opinion from Mr. Durga. The other part is you have to establish that there is no impact on process/material/product cherecteristic due to new resin and it is really equivalent to the earlier one…
Hi, I have a question related to the original question posted in this thread. I have a similar situation, in that a Class II medical device is about to have its LDPE resin discontinued. We have proposed the used of another LDPE which has been validated and is currently used in other devices, but not this product line. Would a full revalidation be required on both biocompatibility and micro (bioburden, sterility etc) be required to qualify its use in this product line? Or can we make a claim of equivalency, as the resin is used elsewhere in our production?
Medical devices attract labelling regulations like pharmaceutical product. You have to lable each component that the device is made up of.
If this product is in a 510k Medical device submitted product, it attracts a change control. This means any material change during manufacturing or packing of medical device shall attract a change control and revalidation all critical parameters.
Its best to contact the nearest regulatory bodies for such crucial descisions.
At times in these blogs you cannot share crucial informations related to type of material that you changed in real situation.
The change here looks sensitive issue.
There might not be a case of equivalent study. It might attract full cycle study.
If you have a related material from competitors you might relate a bio-compatibility study.