CE Mark - Classification Confusion

[Sera Maya]

Hello everyone,

We have recently developed a product that provides an environment where sperm can remain intact for 4 days. You can see a similar product here very quickly vimeo.com/325729477/c3991b26b1 (in case Vimeo link sharing is not allowed, the product called DADI kit; dadikit.com )

I have talked to few different consulting firms from Belgium about CE mark process and all talks differently about classification, I can say. Even one of them said that it is not a medical device.. I am really confused now. Can you please guide me about simple resources related to classification and its process that I can trust? I decided to talk to any kind of company after I really understood the major points.

Thank you very much in advance.

 

[Jen]

Refer to Article 2 of MDR eu 2017/745.

The following products shall also be deemed to be medical devices: — devices for the control or support of conception;

Your product is a medical device under MDR. As for the product classification, you can refer to Annex VIII.

 

[Watchcat]

The MDR is the only authoritative resource regarding what is or is not a medical device under the MDR and for its classification if it is a medical device. Whether is it a simple resource, I leave it to you to decide. The only authoritative interpretations of the MDR are by Notified Bodies, and, perhaps upon appeal, by the Competent Authorities.

In the end, these are decisions your company must make, and for which it, and it alone, will be held accountable. At best, consulting firms can give you their perspective on whether or not they think your product is a medical device, and, if so, its classification, and explain their rationale, with reference to the applicable sections of the MDR, as Jen as done. I don't recommend "trusting" a consulting firm to make these determinations for you.

 

[Ronen E]

I don't recommend "trusting" a consulting firm to make these determinations for you.

Not blindly, definitely, but if they lay out their arguments in an accessible manner then at least the manufacturer can compare and consider which make more sense (at the end of the day, it's not rocket science, and most cases don't fall within thick grey areas).

 

[Watchcat]

Yes, it is the difference between trusting the firm and understanding their rationale. If you can understand their rationale, no need to trust them. If you can't understand it, you have other problems.

 

[Sera Maya]

Refer to Article 2 of MDR eu 2017/745.

The following products shall also be deemed to be medical devices: — devices for the control or support of conception;

Your product is a medical device under MDR. As for the product classification, you can refer to Annex VIII.

That is very helpful Jen, thank you very much. I will read it all in details.

The first impression I got when I read more; our product is a medical device, Class I under the category Class Is. The product we developed is very simple just like a small gadget to keep semen sample alive without any change for four days. No analysing, measuring or any kind of function.

I am just trying to understand the major points and having knowledge about the process roughly to evaluate sayings of firms/people and all.

 

[Sera Maya]

Yes, it is the difference between trusting the firm and understanding their rationale. If you can understand their rationale, no need to trust them. If you can't understand it, you have other problems.

Absolutely! It is also about having a general idea about how the things work to evaluate their sayings. And that is exactly what my intention is in this post. Understanding the major points and having knowledge about the process roughly.

 

[twanmul]

Just to double check - it looks like as part of the service you're doing in vitro analysis of the sperm to check for motility. I take it that you're clear that this is separate to the storage vessel (i.e. not done within the storage vessel) and is using a CE marked diagnostic kit supplied by a third party? The reason I ask is that this would be classed as a Class B under the In Vitro Diagnostic Regulations and may be something you need to consider if this is an assay you've developed in-house.

 

[Sera Maya]

Just to double check - it looks like as part of the service you're doing in vitro analysis of the sperm to check for motility. I take it that you're clear that this is separate to the storage vessel (i.e. not done within the storage vessel) and is using a CE marked diagnostic kit supplied by a third party? The reason I ask is that this would be classed as a Class B under the In Vitro Diagnostic Regulations and may be something you need to consider if this is an assay you've developed in-house.

Hello Twanmul, yes you are right.. I figured out that too.. According to our current regulations 98/79/EC, it is an in-vitro device under General IVDs category. Am I considering right ?

Our product is a home collection kit for sperm, we can say. It does not run any kind of analysis, all analysis will be done by our partnered (already accredited) laboratory. It is a small kit to provide an environment where sperm can live without any change (remain intact) for 4 days from his house until reaching laboratory.

 

[twanmul]

It looks like you have it in hand as you're aware of the existing directive and seem to have a good grasp on the classifications within Annex II.
Your partnered lab should just make sure they are using a CE marked analytical reagent/kit and specimen receptacles as per the instructions for use, though this shouldn't have any bearing on the classification of your device.