Hello Anon,
I guess the first question to clarify is if your device has Notified Body intervention or not, e.g. sterile, measuring, or reusable surgical instruments. If there is no Notified Body intervention there is virtually no oversight so the change in formulation you are wanting to make for EU MDR can all be managed internally. If you do have Notified Body (NB) intervention than need to decide if making the change now under EU MDD is appropriate or if it would be beneficial to make the change at the same time as the EU MDR application. Either way if a NB is involved you would need to look at the timing for the change.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 29-Jun-2022 11:54
From: Anonymous Member
Subject: Class I - MDR change in formulation
This message was posted by a user wishing to remain anonymous
Hi RAPS community,
We're in works for MDR for a class I device (MDD) which will remain class I under MDR as well. However, we're implementing the change in the formulation - removal of parabens and replacing it with preservative with safer clinical profile (we've all the supporting data for this update. One of the other higher class devices have been approved with same preservatives prior to MDR DoA). We plan to draft the technical file using paraben-free formulation and respective supporting information.
My question - Will there be any implications of drafting the MDR tech file with the new formulation? Do we need any prior notification/approval from notified body? Any other suggestion for smoother MDR transition for the device?
Thank you for your support on the matter!