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Here's the situation: We have a product on the market in Europe that is an active implantable and approved per AIMDD. We are expecting to submit a Tech File for a non-implantable this year and our Notified Body says they need to come in and do an "MDD" audit after we submit the Tech File. As our other device complies with AIMDD, and we have ISO13485 certification (both from the same NB, obviously) I'm assuming our QMS is up to snuff. The question is, what should I expect from an "MDD" audit? I'm comparing Essential Requirements lists and the appropriate annexes from EN 13485 and don't seem much differential that I need to worry about. Our risk management has been updated for 2012 EN 14971 (though we argued we could still use labeling as a mitigation per Annex ZB and AIMDD). Any thoughts other than updating Quality Manual and Internal Audit lists to include MDD in scope? Thanks!