My company is adding a weighing unit to a patient hoist, which is a class 1 device according to the MDR.
The weighing unit will be certified as a class III unit according to directive 2014/31/EU by NMi.
Do we need a MDR accredited Notified Body to certify this patient hoist as a class Im device (with a measuring function)?
Or can we do a CE certification covering both the MDR (self certification class I) in combination with directive 2014/31 (class III certification by NMi)?
The weighing unit will be certified as a class III unit according to directive 2014/31/EU by NMi.
Do we need a MDR accredited Notified Body to certify this patient hoist as a class Im device (with a measuring function)?
Or can we do a CE certification covering both the MDR (self certification class I) in combination with directive 2014/31 (class III certification by NMi)?