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CE Marking for Class I Medical Device?

#1
Hi everybody,

I'm new to the Medical Device CE certification requirements, thank you in advance for your help!

We have a medical device for a smell=test, (4x6 inch card with smell areas, scratchnsniff) ol-factory dysfunction or lossofsmell. Based on what I have seen in MDD, we have a Class I device. Device is not sterilized, not taking any measurements, should be the lowest Class I categorization. We have a local representative in Germany with 35 years of med device experience.

As Class I devices are self-certified, all we have to do is:
1. compile a technical file and design file -which directive would be the appropriate one?
2. demonstrate compliance with the essential requirements. -Is there any other requirements than local rep? Do we need a QMS?
3. sign our own declaration of conformity
4. register with German competent authority to say that we intend to market the device

Am I missing a step? -or are we in CE compliance with these basic steps?

Thanks for your help!

kimmo01
.
 
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DannyK

Trusted Information Resource
#2
I am working for a client with a class I medical device and these are the activities required for class I as required in EU MDR (2017/745)

1. Classify the device as per EU MDR chapter III.
2. Create a Declaration of Compliance as per Article 19
3. Create a Post Market Surveillance Plan as per Article 84
4. Create a Post Market Surveillance Report as per Article 85.
5. Technical documentation as per Annex II.
 
#3
Hi Danny K,

Thank you for your prompt response! We have a smart phone app tied into this test, so the questions are: does a smart phone app have a different Class I spec? Can we combine the card and the phone app into one single declaration of conformity?

Thanks!
 

Mikilk

Involved In Discussions
#4
I am working for a client with a class I medical device and these are the activities required for class I as required in EU MDR (2017/745)

1. Classify the device as per EU MDR chapter III.
2. Create a Declaration of Compliance as per Article 19
3. Create a Post Market Surveillance Plan as per Article 84
4. Create a Post Market Surveillance Report as per Article 85.
5. Technical documentation as per Annex II.
They also need to make sure they have QMS in place and the technical documentation should include Annex II+III
 
#5
Hi Danny K,

Thank you for your prompt response! We have a smart phone app tied into this test, so the questions are: does a smart phone app have a different Class I spec? Can we combine the card and the phone app into one single declaration of conformity?

Thanks!
Hi kimmo01,

I am involved in the preparation of the CE conformity of smart phone apps and, in addition to CEP, CER, I also write risk management files and usability reports. In Germany, certain smart phone apps can be approved as digital health applications. These must be Class I or IIa. Once approved, these are added to the directory of reimbursable digital health applications and can be prescribed by the doctor and reimbursed by the health insurance companies. This is regulated in accordance with the German Digital Health Application Ordinance (DiGAV). However, they need a CE mark - the MDR is used here.

Background in relation to your question:
Your intended purpose is decisive! If your intended purpose is Class I or Class IIa, then you can approve your app as a medical device and that works in combination with the card. Note that the app has to fulfill the main function of the intended purpose! I.e. the card is only allowed to measure, but the data processing is up to the app! CEP and CER must then be carried out in combination with the app + card, unless your app can also be approved as a medical device without the card and carry out the functions. Then the app can also be approved on its own. Of course, this also applies the other way around. If you just want to allow the card and don't need the app

Answer to your question:
Smart phone app can be class I, yes. BUT as I said: your intended purpose classifies your device (in combinationwith the card or alone). Check out: Rule 11! But also be aware of any inhalation via body orifice (if applicable to your device).
To define your intended purpose regarding rule 11: Is your app therapy crucial? or for Diagnostic purposes? Than, it is likely to be IIa! But if you "just" provide the test to measure something and support monitoring it is likely to be class I
Consider also (but this is up to you) if your device can be an IVD (IVDR applies here)
Best regards, I hope I could give you valuable input
 

chris1price

Trusted Information Resource
#6
1. Classify the device as per EU MDR chapter III.
2. Create a Declaration of Compliance as per Article 19
3. Create a Post Market Surveillance Plan as per Article 84
4. Create a Post Market Surveillance Report as per Article 85.
5. Technical documentation as per Annex II.
Regarding your list, please remember that creating and signing the Declaration of Conformity should be the very last thing you do, as essentially, you are declaring that everything else has been done.
 

Raisin picker

Involved In Discussions
#7
Just for the record: under MDD, most software is classified as class I. Under MDR however, almost all software will be class IIa or IIb. Keep that in mind while preparing PMS/PMCF plan, since you will have to provide at least some own clinical data once you apply for MDR with a class II device.
 

dgrainger

Trusted Information Resource
#8
You will need clinical evidence that it is safe and performs as you intend - sounds novel, is there an equivalent device or do you need to perform a clinical investigation?
What chemicals are you using? Have you performed biocompatibility tests?
Does the combination device "allow direct diagnosis"? = Class IIa under MDD.
 
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