Hey Elsmar Cove, hoping someone here could help me shed a bit of light on my issue.
We're manufacturing hospital beds in North America, but we're soon wanting to market in the UK market along with Europe eventually.
Now, my dilemma comes from whether or not our product is classified as having a "measuring function". We have a scale on our beds, but strictly for reference only, as indicated in our user's manual. It is not intended to be used for dosage or medical treatment.
MEDDEX 2.1/5 is a guideline pointing me towards that we do not have a "measuring function" since criteria A (it is not intended to measure a parameter) and C (accuracy can't lead to adverse effect on the patient, since it's stated to be used as a reference only) are not met.
2017/745 section 6.2 (f) wouldn't be applicable since it does not have a "measuring function"
2017/745 section 7 (b) would also not be applicable for the same reason
93/42/EEC section 10 (with sub sections 10.1 and 10.2)
Am I right for thinking that our product does NOT have a measuring function based on the documentation available?
EDIT : just realized there's a better sub-forum for this, if a mod would move it there it would be greatly appreciated, thanks in advance.
We're manufacturing hospital beds in North America, but we're soon wanting to market in the UK market along with Europe eventually.
Now, my dilemma comes from whether or not our product is classified as having a "measuring function". We have a scale on our beds, but strictly for reference only, as indicated in our user's manual. It is not intended to be used for dosage or medical treatment.
MEDDEX 2.1/5 is a guideline pointing me towards that we do not have a "measuring function" since criteria A (it is not intended to measure a parameter) and C (accuracy can't lead to adverse effect on the patient, since it's stated to be used as a reference only) are not met.
2017/745 section 6.2 (f) wouldn't be applicable since it does not have a "measuring function"
2017/745 section 7 (b) would also not be applicable for the same reason
93/42/EEC section 10 (with sub sections 10.1 and 10.2)
Am I right for thinking that our product does NOT have a measuring function based on the documentation available?
EDIT : just realized there's a better sub-forum for this, if a mod would move it there it would be greatly appreciated, thanks in advance.