MDR Classification Rule 10

[Chr1sG]

Thanks everyone for the valuable dialogue.

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

Yes, perhaps I was a bit flippant with my wording.
I suppose that I was wondering what would happen if we determined that we were Class I (and therefore didn't need to speak with a NoBo) and then a competitor raised a flag with the CA, suggesting that we were mistaken and should be Class IIa or higher.

If there is ambiguity in the classification rules (which I feel that there is) then it just makes things uncomfortable. Conversely, I'm not actually uncomfortable with the level of risk associated with the product.

Of course, if the decision about right/wrong ends up with lawyers arguing over the effect of the absence/presence of a comma in the regulations, then things have probably escalated beyond what is reasonable!

Ultimately, I guess what I don't want to do is ask for an opinion from an NoBo since a) it will cost money b) they are incentivised to make a Class II determination when faced with the choice between Class I and II (consciously or sub-consciously, for financial or CYA reasons) :-(

 

[dgrainger]

Why don't you just ask your CA?

 

[Chr1sG]

Why don't you just ask your CA?

In previous roles I have held, they have not proved themselves to have the bandwidth/enthusiasm/willingness to engage with companies on this sort of issue - as @Watchcat suggested, they would rather let the NoBos do the work.

Me: "Do I need a NoBo?"
CA: "We suggest you consult a NoBo"

Obviously, even without my remark about the conflict of interest for NoBos in making such a decision, as we all know getting a NoBo to even answer the phone these days is nigh on impossible because of the supply/demand asymmetry that the MDR introduction has created, but that's a whole other story :-(

 

[Watchcat]

Certainly the MHRA

Yes, if the answer was "only one," and I were asked to guess which one, I would have guessed the MHRA in a heartbeat. I am very interested to see if any of this change under the MDR. IMO, unless the CAs are willing to be actively involved in oversight, there is only so much you can expect.

I can't say I'm optimistic, because it seems the main lesson learned under the MDD was not that they need to be more actively involved in oversight, but that, if they don't want not being actively involved in oversight to come back on them politically, they need fewer, better NBs, rather than more, not always so great NBs. I agree this should lead to improvement...eventually, but still.

 

[Muhammad Ahmad Azhar]

Hi,
I have a question regarding classification of 2 devices.
First is Ophthalmoscope, I am a little confuse if Ophthalmoscope will be in Rule 10 or Rule 13 according to MDR.
Second is Laryngoscope, We believe that Laryngoscope is an active MD, but i attended a training session, They classify Laryngoscope as non-active Medical Device. My Question is if a Laryngoscope is an active or non-active medical device as it have power source in its handle (batteries).
(Please include reference in your asnswer)

Thank You for this amazing forum, the Guidance i get here is very helpful.

 

[Bonebuilder]

Hi,
I have a question regarding classification of 2 devices.
First is Ophthalmoscope, I am a little confuse if Ophthalmoscope will be in Rule 10 or Rule 13 according to MDR.
Second is Laryngoscope, We believe that Laryngoscope is an active MD, but i attended a training session, They classify Laryngoscope as non-active Medical Device. My Question is if a Laryngoscope is an active or non-active medical device as it have power source in its handle (batteries).
(Please include reference in your asnswer)

Thank You for this amazing forum, the Guidance i get here is very helpful.

IMHO It's clearly rule 10 for both. They both depend on a source of energy and convert what I presume is electrical energy into light thereby satisfying the criteria defined at Article 2(4) for an Active Medical device.

So as an Active Device which rule to apply? Well without getting into a long debate as to whether either an Ophthalmoscope or a Laryngoscope provide a diagnosis or monitor the patients health they clearly both deliver energy intended to illuminate the patients body therefore you'd be safe to rely on the first sub-paragraph of Rule 10 -

Rule 10

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, except for devices intended to illuminate the patient's body, in the visible spectrum, in which case they are classified as class I;

 

[dgrainger]

Have a look at the new MDCG 2021-24 - Classification guidance: https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-24_en.pdf

It has guidance on illumination:

"Note 1: ‘Illuminate’ means: to administer rays in visible light spectrum to for use in the process of diagnosis for example in visual​

electrophysiology and eye diseases, and not just to cast a light to improve the visibility. When performing diagnosis to, for example, perform​

visual electrophysiology in search of eye diseases, the intended purpose of the device is not limited to ‘illumination’, but may include diagnosis."​

So a manufacturer's claims could? put a Ophthalmoscope/Laryngoscope into clause 3 if allowing 'direct diagnosis'.