F
Francesco Sgarro
Hi all,
can you clarify this doubt about this standard? is it recommended or mandatory for devices manufactured after June 2013 in Europe?
my understanding is that 2 devices intended for use in homecare environment are equivalent if they are compliant to MDD 93/42 (first device - manufactured before june 2013) and 60601-1-11 ( second device - after June 2013).
is there any competitive advantage versus devices that are not compliant with these standard?
thank you for your help
can you clarify this doubt about this standard? is it recommended or mandatory for devices manufactured after June 2013 in Europe?
my understanding is that 2 devices intended for use in homecare environment are equivalent if they are compliant to MDD 93/42 (first device - manufactured before june 2013) and 60601-1-11 ( second device - after June 2013).
is there any competitive advantage versus devices that are not compliant with these standard?
thank you for your help