Measuring Function MEDDEV 2.1/5 relation with MDD 93/42/EEC

[Kuldeep Singh]

Hello!

We are introducing our self as Manufacture of X-Ray Medical Devices fall under Class IIb as per MDD 93/42/EEC. During our last surveillance audit , we got a Non Conformity on MDD 93/42/EEC , Annex 1 Essential Req. 10 "Device with a Measuring Function". We selected as N/A , as per our concern there is no such Measuring device in our ME Equipment's , which can help the operator to perform the procedures or anything to achieve the intended use. Although there is Dose Area Product (DAP) used in our devices to show dose delivered to patient. However it doesn't enable the x-ray, just calculate the dose delivered.

After a long discussion with auditor, he just referred us MEDDEV 2.1/5 https://ec.europa.eu/docsroom/documents/10283/attachments/1/translations/en/renditions/pdf and gave us the NC to take appropriate actions according to requirement.

Can anyone help us for our below queries?
1. After reading the MEDDEV 2.1/5 , it seems that, all the devices and examples showed in this guideline, they are just intended to use for measurements like thermometer.
2. MDD 93/42/EEC EHSR 10 i.e "Device with a measuring function" is this requirement applicable to devices intended for measurement or devices with any measuring device?
3. If there is any measuring function in our devices , like measuring scale, angular rotation, applied force etc which are not helping the operator to enable x-ray or achieving intended use. these are just use for operator guidance only. In that case our devices will become measuring device? and falls under Requirement MDD EHSR 10.

Further , Our ME Equipment are not intended for measurements however some measuring devices are used in our ME Equipment , just for ease or operator's comfort.

 

[Jean_B]

Guidance, not a requirement. But you'll have a tough nut argueing it.

Going through it:

A is true as radiation = "- a quantity or a qualifiable characteristic of energy or of substances delivered to or removed from the human body."​

​

B is the stickler, as you might not 'measure' it, but have it calibrated to provide relative to some adjustable parameter and the output is a legal (SI)/acceptable unit in graduated increments. Note 2 states: "Measuring activities during the manufacturing process including those for calibration purposes are not covered by this recommendation and do not imply a measuring function of the manufactured device." Furthermore, you might be recalibrating it after the user has put it into service, which could be considered to fall under service, not manufacturing, and that drift has its own risks.​

​

C is true as you have implied accuracy through expectation, where non-compliance can result in significant adverse effects (under or overdosage).​

​

Without knowing more a definite conclusion cannot be reached, but given my expectations when you say x-ray (whether diagnostic or therapeutic), unless hard-limited to non-hazardous limits, I would tend to consider the measurement accuracy and stability concern as valid.

 

[Al_Z1]

Hello.
We've got nearly the same NC, according to our device (X-ray therapy). After analyzing all the info about classification and intended use from MDD, I couldn't find any information directly defining, what is device Class IIb with measuring function. Furthermore, as i suppose, ER 10 from MDD has to be based on the intended use of the device, which is not to measure anything, but, for example, to get x-ray image (in the case of X-ray imaging device). All the other functions of the device are secondary, and just help to deliver the intended use of the device.
Also, according to the Meddev 2.1/5, it seems to be used for the Class I devices, as its background says:
"Annex VII, paragraph 5 of MDD requires for class I devices with a measuring function that the manufacturer must also follow one of the procedures referred to in annex IV, V or VI, for the «aspects of manufacture concerned with the conformity of the products with the metrological requirements »".
I guess, this whole ER and it's implementation is kinda fuzzy for the complicated devices, which main function is not direct measure.