MDD 93/42/EEC, Annex IX - Class IIa vs IIb: "Potentially Hazardous" definition

M

mr.mike

#1
Hi Once Again, :bigwave:

We are presently developing an active therapeutic device, and would like to know what the MDD classification would be.

So, to the MDD 93/42/EEC, Annex IX we go...
And for our device the determining rule is Rule 9 (3.1) which states:

"All active therapeutic devices intended to administer or exchange energy are in Class IIa unless their characteristics are such that they may administer or exchange energy to or from the human body in a potentially hazardous way, taking account of the nature, the density and site of application of the energy, in which case they are in Class IIb."

So, then, the question is what constitutes "potentially hazardous"? I presume the interpretation of this would be left to an NB?

It is frustrating that this is so vague. It may explain why my research into similar existing devices on the market seem to show no consistent classification of either IIa or IIb (different NB's interpreting differently?).

Are the "nature, the density and site of application" referring only to intended use and non-fault conditions? If so, our preliminary risk analysis and assessment indicates that the current delivered is sufficiently low that electrical-hazards are mitigated. Also, the energy delivered is only intended for peripheral limbs, and is intended to be delivered transcutaneously only.

Is this sufficient arguement to argue in favor of a Class IIa classification?

Anyone out there have any experience with the interpretation of this particular classification rule?

Thanks in advance,
MM.
 
Elsmar Forum Sponsor
#2
We too make a device that applies energy trans-cutaneously to the periphery and we classify that as class 11a. The energy is limited to that considered safe in the particular standards (in our case 60601-2-10 and -2-40).

But the difference between the a and the b class may be not important for your company. If you have the Annex II 'full quality assurance system' the difference between the sub-classes is small. Compare paragraphs 7.2 and 7.3 of annex 11. (latest M5 version).
 
S

SteveK

#3
Hi Once Again, :bigwave:

We are presently developing an active therapeutic device, and would like to know what the MDD classification would be.

So, to the MDD 93/42/EEC, Annex IX we go...
And for our device the determining rule is Rule 9 (3.1) which states:

"All active therapeutic devices intended to administer or exchange energy are in Class IIa unless their characteristics are such that they may administer or exchange energy to or from the human body in a potentially hazardous way, taking account of the nature, the density and site of application of the energy, in which case they are in Class IIb."

So, then, the question is what constitutes "potentially hazardous"? I presume the interpretation of this would be left to an NB?

It is frustrating that this is so vague. It may explain why my research into similar existing devices on the market seem to show no consistent classification of either IIa or IIb (different NB's interpreting differently?).

Are the "nature, the density and site of application" referring only to intended use and non-fault conditions? If so, our preliminary risk analysis and assessment indicates that the current delivered is sufficiently low that electrical-hazards are mitigated. Also, the energy delivered is only intended for peripheral limbs, and is intended to be delivered transcutaneously only.

Is this sufficient arguement to argue in favor of a Class IIa classification?

Anyone out there have any experience with the interpretation of this particular classification rule?

Thanks in advance,
MM.
Hi MM,

I think I have touched on this in another thread. However the way I have interpreted “potentially hazardous” is by this example. An oxygen gas regulator typically reduces cylinder pressure (to administer oxygen to a patient – Annex IX Rule 11 rather than 9) from 137 bar to 4 bar. Because of the potentially high pressure and the fact that oxygen can cause an explosion/fire in such devices, they are classified as Class IIb, rather than IIa out there on the market. Oxygen flowmeters on the other hand only deal with low (4 bar) pressures so these tend to be classed as IIa. However, some manufacturers class them a Class IIb because (I guess) of the potential hazard of oxygen even at low pressure. So there is a degree of interpretation - which I believe is down to the manufacturer. Incidentally, I submitted a TF to a NB for a flowmeter classed as IIa and they did not question this. I suppose in the Rule 9 case it could be that a particular battery operated device (linked directly up to a patient) is Class IIa, whilst mains operated device is Class IIb. I don’t know if this helps or hinders!

Steve
 
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