What are the mandatory minimum requirements to get approved the resterilization of the EU MDD implants (class IIb or higher). These ceramic implants were sterilized once, are not-expired and the plan is to sterilize them once with the same process used for the first sterilization. What must be done to get them approved? Is the involvement / approval of the notified body mandatory required to have this approved? Can you provide advice? Thank you!
We will need to know more details like why the resterilization is being proposed; who will be doing the resterilization and where (i.e., in-house, hospital, etc.); what is the associated impact on the shelf-life (e.g., will the devices be relabeled with a new shelf-life); what packaging changes if any will be involved, etc., etc.
In the meantime, a couple of initial thoughts for me are that if the subject devices will be relabeled with a new shelf life as part of this, and if the relabeled shelf life via resterilization was not part of the original shelf life protocol previously approved by the notified body, then that could be a significant change disqualifying the subject devices from their presumed Union MDR Article 120 legacy status. The notified body should be consulted about its interpretation of that for this case.
Whether or not the change impacts the validity of the Article 120 legacy certificate and whether or not the notified body needs to preapprove such a change, the resterlization process and its impact on the subject device, its integrity, its packaging integrity, its material integrity, its SAL, its usability (e.g., if users will be resterilizing rather than the original manufacturer), etc., need to be fully vetted via proper corresponding design and development controls before the affected subject devices can be placed on the market or made further available on the market.
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