CE marking of MD and IVD set

[gkrehal]

Hi all,

I was hoping for some clearance and guidance.

We have an already marketed a class IIa single use and sterilised medical device and a self-certified single use and sterilised IVD, which is classified as a General IVD (self-certified) under the current EU IVD Directive.

Now we want to market above products as one "new product. In our new product we are combining the MD and IVD and giving them a sterilisation together and new packaging. So you could say, we are now providing the two seperate products as one "sample set".

Would both products then require a CE mark with notified body number? The IVD will still remain as self-certified, so it does not make sense to put the CE mark for notified body on that - or will the notified body see this new product as "one" unit?

Please let me know what you think about this or if you have any concerns, Thank you in advance

 

[LukasLosigkeit]

You can combine products in a system or procedure pack. Each component, if an individual product, bears its own CE mark (the CE mark they received during product registration independently from the system/procedure pack. You do not change these CE marks.

The system or procedure pack will be assigned a CE mark.

If you add the NB number to the self-declared IVD, you falsify the labeling. Do not do that.

 

[L_O_B]

The system or procedure pack will be assigned a CE mark.

Systems and procedure packs are not assigned a CE mark on their own. Assigning a CE mark would imply that someone declared conformity for the combination with regulatory requirements. For the procedure described in article 22, this is not the case. Additionally, systems and procedure packs are not "devices" by the meaning of the regulation (see article 1(4)). Therefore, they are not required to bear a CE mark according to article 20(1).

@gkrehal
You are not allowed to use article 22 until the MDR applies in May next year. If you want to place your combination on the market as a procedure pack, you must follow the national requirements transposed from the MDD article 12.
Regarding the CE markings, the requirements are the same:
1. Each device retains its individual CE mark.
2. The packaging of the procedure pack does not bear a CE mark.

 

[LukasLosigkeit]

Clarification regarding when the system / procedure pack receives a CE under MDR:

"Where the system or procedure pack incorporates devices which do not bear the CE marking or where the chosen combination of devices is not compatible in view of their original intended purpose, or where the sterilisation has not been carried out in accordance with the manufacturer's instructions, the system or procedure pack shall be treated as a device in its own right and shall be subject to the relevant conformity assessment procedure pursuant to..."