Hi,
if general class I medical device (e.g. wheelchair, hospital bed, crutch,...) is coated by nanomaterial do I need to use classification MDR rule 19 and re-classify the device? That means, if I cover e.g.handle of a crutch by nano-layer, is it automatically higher class than class I?
Intended use of the coated device is still the same, but surface can have e.g. antimicrobial properties. It is very often used now, and not only in healthcare sector.
Thanks for sharing of your opinions/experience.
if general class I medical device (e.g. wheelchair, hospital bed, crutch,...) is coated by nanomaterial do I need to use classification MDR rule 19 and re-classify the device? That means, if I cover e.g.handle of a crutch by nano-layer, is it automatically higher class than class I?
Intended use of the coated device is still the same, but surface can have e.g. antimicrobial properties. It is very often used now, and not only in healthcare sector.
Thanks for sharing of your opinions/experience.
