Why is it important with a CE marked scale on the medicine measures?
We would like to inform you about some very important rules that exist for the medicine cup regarding how the product should be marked in order to fulfil the Medical Device regulations 93/42/EEC for dispensing cups used for both oral medicine and tablets on the European market.
Our medicine cup 30 ml, used both for fluid medicine and tablets,is classified as a class 1M product.
You can read in Annex VI:
“The manufacturer affixes the CE marking in accordance with article 17 and draws up a written declaration of conformity. The CE marking must be accompanied by the
The Notified Body Number signifies that the product is following the regulations of class 1M, where the Notified Body i
s inspecting the manufacturing company regarding the calibration of the scale.
Our Notified Body number 0413, implies that our N.B, Intertek, inspects our calibration system of the medicine cups and controls that we follow the manufacturing rules of the product according to the Medical Device regulations.
An exact scale is very important when you distribute medicine to a patient. Note that the medicine description always prescribes an exact dose. If the product is not marked with Notified Body number the scale can not be trusted.
If you overdose the medicine to the patient increases the risk of side effects, and if you give the patient too little medicine reduces the desired effect, which may pose discomfort to the patient.
This is especially important with small children where the given dose of medicine is based on the weight of the child to be exact.
Hammarplast Medical manufactures medical devices and is well educated in the Medical Device Regulations. We ensure our customers that the products provided by Hammarplast Medical are in order according to the MDD regulations.