Can remote installations and trainings be declared and documented as a formal training according MPG and MPBetreibV?
Our trainings and installation can be declared and documented as a formal training before the use of the medical products according to the German MPBetreibV („Einweisung in die ordnungsgemäße Handhabung des Medizinproduktes“ lt. §4 Abs. 3 MPBetreibV).
This training ("Einweisung") needs to be done by a "Medizinprodukteberater" (which everyone in IBA handling customer feedback from Germany is) and it can be provided remotely according to §31 MPG Medizinprodukteberater ("fernmündliche Information").
This is also the case for the new MPDG (mandatory in Germany beginning from May 26, 2021). See §83 Medizinprodukteberater ("fernmündliche Information").
Despite this we still state that from a regulatory point of view our products do not require such a training and can be used solely based on the User's Guide.