MDR Classification Rule 10

[Chr1sG]

This may sound as though I am being pedantic, but if I was a lawyer, and the wording of Rule 10 were used in a legal contract, I believe the first clause could have (at least) two possible interpretations.

"Active devices intended for diagnosis and monitoring are classified as class IIa
— if they are intended to supply energy which will be absorbed by the human body ..."

What does this mean for a device where energy absorption is not intended (or necessary for operation)?

I see a distinction between
'they are intended to supply energy-which-will be-absorbed'
and
'they are intended to supply energy, which (as an unfortunate side-effect) will be absorbed (whether this is intended or not)'

From a physics point of view, let's assume that energy supplied to the body can be either reflected, transmitted or absorbed.
Of course, for something like an x-ray machine, the both absorption and transmission are absolutely necessary for its function, but there can be devices where the amount of absorbed energy is of no concern (for the device).

Hypothetical example:
The patient stands in front of a light source and the shadow cast by the patient on a large sheet of paper is used to make an estimate of their volume (and this info is used for some diagnostic/therapeutic purpose). The functioning of this device only requires that the light supplied by the source is not transmitted through the patient (it can be reflected or absorbed, who cares).
The amount of energy that will be absorbed will no doubt depend on the wavelength of the light, but absorption is not required (or 'intended').

Similarly, there are other examples I can think of where reflected energy is necessary for the device operation, and absorption/transmission is of no concern.

Or at the most ridiculous level, if a device is providing info via an illuminated display of some sort, then it is supplying energy, and a fraction of this energy will be absorbed (by the cells in the retina in order for the information on the display to be perceived!)
Does that automatically make such a device Class IIa?

Any thoughts?

 

[dgrainger]

Probably the second of your interpretations. The risk is there even if the energy absorption isn't intended.

 

[Chr1sG]

So, does that mean that any energy emitting device is Class IIa (*) irrespective of whether energy absorption plays no part in the intended use?

(* except if it only emits visible light for illumination of the body)

So my example of a device with a display that emits light (not for illuminating the body, but for presenting clinical data) is Class IIa?
Surely not?

As I say, I am not a lawyer, but I imagine that this interpretation is possible, in which case, lots of Class I device manufacturers are screwed ;-)

 

[dgrainger]

I would say that this relates to the interaction with the patient and not the user.

 

[Chr1sG]

I would say that this relates to the interaction with the patient and not the user.

And if the patient is the user?

 

[Chr1sG]

I suppose it frustrates me that the most important piece of legislation for the industry in the EU has been written in a way that is so wide open to interpretation. Why didn't they get a pedantic lawyer to point out these things?

Google 'BBC the-commas-that-cost-companies-millions' and you'll see what I mean ;-)

 

[Watchcat]

I suppose it frustrates me that the most important piece of legislation for the industry in the EU has been written in a way that is so wide open to interpretation. Why didn't they get a pedantic lawyer to point out these things?

All law is open to interpretation. That is what the courts are for. Lawyers represent parties who would like it interpreted to their benefit, or at least not to their loss. I call confusing language in a law or contract "lawyer bait." I don't think lawyers have much motivation to stomp out confusing wording in the law. They obsess over legal contracts that they themselves draw up for clients, because they want their interpretation to be clear enough that their own interpretation, intended to serve the interests of their client, will win if challenged. Even so, the bullet-proof contract does not exist.

I concur with dgrainger. Device class is determined by risk, not by legal definitions. If the risk is the same regardless of intent, how you interpret this wording is irrelevant to classification.

 

[Chr1sG]

Thanks @Watchcat

I concur with dgrainger.

Are you concurring with dgrainger that the 2nd interpretation is what was meant by the authors
or
are you concurring that the energy 'absorbed by the human body' relates solely to the patient
or
both of these?

If the risk is the same regardless of intent, how you interpret this wording is irrelevant to classification.

So, assuming that the intent of this rule is to classify devices as IIa (or higher) based on the fact that energy will be absorbed by the (patient's) human body (irrespective of whether it is intended or not), then what level of energy absorption is allowable (sufficiently low risk) that a device can remain in Class I?
Given the large gap in cost/resource impact between Class I and Class IIa, it would seem to me that this is quite an important question to answer...

Device class is determined by risk, not by legal definitions.

Hmmm...that's quite a bold statement. Do you think that argument would satisfy a competent authority who came knocking and asked why a company didn't get a notified body involved?

 

[Watchcat]

Has any CA ever come knocking at the door of a medical device company? Not trying to suggest that this has never happened, but I would be curious to know. My limited experience with the EU MDD gave me the impression that the CAs mostly handed the entire thing off to the NBs and then went back to whatever they were doing before they were so rudely interrupted by medical devices. Seriously, is anyone aware of this having happened, except maybe post-disaster, as in the mess with the PIP implants?

But to answer your question...

I would never begin to predict what would satisfy any regulatory authority that comes knocking at your door, assuming you have been gamely trying to satisfy them all along, rather than hide out and hope they don't notice. I wouldn't bet money that the authority understands anything any better than you do. Nor that they haven't been blown there by political winds that will toss everything out the window and they will do whatever satisfies the politics, regardless of legal definitions or requirements.

I will say that I don't have any more confidence that you will satisfy them by standing on a legal definition than a risk-based framework. the legal definitions come into play later, if the authority is not satisfied. To quote a colleague who started in Legal and transferred to RA, "Legal steps in when RA fails." So I guess the way I see it is that, if you are RA, and you are pointing to legal definitions, to some extent you have already failed, whether an authority shows up or not.

 

[dgrainger]

Has any CA ever come knocking at the door of a medical device company?

It does depend on the CA. Certainly the MHRA used to run class I device manufacturer audits and regularly participated in the global Operation Pangea - mainly counterfeits UK medicines regulation: responding to current challenges

On the whole, regulation in the UK is by persuasion as the enforcement options under the MDD are rather blunt - the safeguard clause.

This will change in the GB with a range of actions being introduced including civil action as well as a range of criminal options.