The current proposal may affect the classification of several products by putting these in a higher class, which is not justifiable as the duration of contact between a device and a patient is not the unique factor for determining the risk classification.
Šis priekšlikums var ietekmēt vairāku ražojumu klasifikāciju, paaugstinot attiecīgo ražojumu klasi, un to nevar pieļaut, jo ierīces un pacienta kontakta ilgums nav vienīgais faktors, kas nosaka risku klasifikāciju.