Over-labelling the manufacturers name at the front of the device

pkost

Trusted Information Resource
#21
I think they are fundamentally misinterpreting the meaning of "an additional CE mark"; this refers to applying a CE mark to the procedure pack itself.

what do they define as a CE mark? It is merely a symbol. Are they saying it is a single product? or a single product group (i.e grouped within a technical file?)? Are they saying that you as a manufacturer only have a single CE mark for all your products? - What a load of rubbish

Taken from the directive: "Whereas medical devices should, as a general rule, bear the CE mark to indicate their conformity with the provisions of this Directive". A CE mark holds no intrinsic value, it is nothing but a symbol. Medical devices must undergo conformity assessment and as evidence of this they are CE marked, by way of derogation, devices that have already undergone conformity assessment can be bundled together but should not have an additional CE symbol added (as they have not undergone conformity assessment)

I'm glad I'm not in your position, I'm not sure I would be able to maintain an air of professionalism in front of whoever you are talking to.

I would recommend speaking to the competent authority and getting their, hopefully, more rational opinion.


The only scenario I can see where a notified body needs to be involved is if you wish to remove the manufacturer details from the OEM product and apply your own, this is outside the scope of article 12 and from my understanding of your posts not something that you want/intend to do

[edited with a helpful addition to your attachement]
 

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robert.beck

Involved In Discussions
#22
it took me a while to parse your comment, but in the end I agree with you. the answer is to remove the CE mark from the outer procedure pack box. the only chink i can find is the statement by Emergo on this topic at Are you considered a medical device manufacturer?, where it is stated, " It is advisable that if the class of the system or procedure pack would require notified body involvement (Class I sterile or measuring, Class IIa, Class IIb or Class III), the manufacturer should consult with the notified body about the applicability of this article to its device. "
This means that just about any device that involves one's NB requires NB approval of the approach to this article, and we got told that additional conformity assessment is required. We may go back to the NB with these more powerful arguments but that hasn't happened yet.
 

RobertvanBoxtel

Involved In Discussions
#23
I complete agree with @pkost , this is a very strange situation. Article 12 allows for procedure packers to combine CE marked products together and place them on the market without an additional CE. It does not make any restrictions on the devices being CE certified by one and the same NB. Removing CE's from labels (or hiding them) is not allowed.
If you place your CE on the outside of the procedure pack, you are manufacturer and need to take responsibility for all products inside, and follow Article 11.
 

robert.beck

Involved In Discussions
#24
The 'additional CE' seems to be the source of this problem. I think removing the CE mark from the procedure pack box solves the problem. i can't find any requirement to have a CE mark on this outer boxing. everything in the box is CE Marked because it has gone through a conformity assessment.

where this gets fuzzy is about software. one of the components of this procedure pack is a Smartphone with an App. another component is a back-end analysis software residing on a server. this entire 'system' has been CE marked and gone through at least two technical file reviews. the problem arose when a sensor was replaced by an OEM sensor. both sensors are CE Marked, and the NB thought this was one too many CE Marks on the procedure pack because the OEM sensor has its own CE mark from a different NB. it is integrated into this 'system' or procedure pack as a direct replacement. does this break the conformity assessment of the original system? that is essentially what the NB says under the guise of article 12, and the NB wants to do a review of the replacement sensor so they we can keep their CE mark on the entire packaging.

it would be extremely helpful to find an existing procedure pack that is on the market in the EU and consists of components from multiple sources, so that at least one component is an OEM component. does anyone know of a product like this or have good suggestions for finding one. I have spent considerable time with Google searches but haven't turned up much that's useful.
 

pkost

Trusted Information Resource
#26
This probably should be another topic, and I'm being deliberately provocative. because it's an interesting question - I'm unware of any precedent.. The directive doesn't define package and therefore you can't infer that it means the items have to be in close proximity, a software package is a concept and not a physical item, it is well known and understood. It seems reasonable to me to sell a product that links to a computer and then bundle in the license key for some software that is in the cloud, this strikes me as a system for which article 12 is appropriate

@dgrainger - is it your viewpoint or one that has been communicated by the MHRA? I'm not sure your position would stand up if challenged
 

Ronen E

Problem Solver
Staff member
Moderator
#27
FWIW, I think that the Article 12 concept is more about having verified that all included items work together safely and effectively, in line with the Intended Uses assigned by their original manufacturers, not so much about packaging or otherwise logistically associating them.

MDD language long predates the e-health age so I would be cautious to read any software-related meaning into it.
 

robert.beck

Involved In Discussions
#28
It can't qualify as part of a system unless packaged together!
good point, but not quite relevant. The back-end software is mentioned in the IFU.

there are two systems here. one is the real world system, which not at all unusually, includes modern software algorithms that require a lot of computing power to complete their complex analysis of complex data in a reasonable amount of time. this level of computing power today is mostly available on servers and they usually reside in a special place called a data center. it's not unusual to have a simple device which includes a sensor that transmits physiological signals to a distant location for detailed analysis. what is more important is whether this analysis is diagnostic or informative to a physician's diagnosis.

the second system is the one defined by the MDD regulations. in the US these are often called 'kits' and in the EU they're known as procedure packs. FDA has wisely chosen to not get involved with data centers and servers, but does look at the clinical impact of the algorithm.

The hiccup we're having with the NB is that one of components, which is CE marked by a different NB, was substituted for a component that was CE Marked as part of the real-world system. The NB is saying that they need to evaluate this component and is using article 12, section 4 as the pretext for doing so. This has devolved the issue into one of labeling.

The approach i plan to take, if possible, is to identify one or more procedure packs currently on the market, examine their labeling, and make sure we do something very similar. Finding a good example is turning out to be more difficult than I thought.
 

robert.beck

Involved In Discussions
#29
FWIW, I think that the Article 12 concept is more about having verified that all included items work together safely and effectively, in line with the Intended Uses assigned by their original manufacturers, not so much about packaging or otherwise logistically associating them.

MDD language long predates the e-health age so I would be cautious to read any software-related meaning into it.
You're talking about the "spirit" of the regulation, not the "letter" of the regulation. Most regulatory agencies focus on the letter. It's tough to find an auditor who looks at the spirit of the rules because that leaves them open to charges of laxness. This is a basic distinction that is millennia old.

Medical device innovation is proceeding at a much faster pace than the evolution in regulations, and when regulations evolve it's typically in reaction to an unwanted situation, meaning that the regulations are expanded in attempt to have everything written down somewhere. Just look at how ISO 60601-1 has increased in length over the last couple of revisions.
 

Ronen E

Problem Solver
Staff member
Moderator
#30
You're talking about the "spirit" of the regulation, not the "letter" of the regulation. Most regulatory agencies focus on the letter. It's tough to find an auditor who looks at the spirit of the rules because that leaves them open to charges of laxness. This is a basic distinction that is millennia old.
I'm aware of that. That's why I wrote "FWIW".
 
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