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Procedure Pack - KIT - Each has its own CE Mark

B

belemsanchez

#1
I have a doubt, my company sell our MD together some accesories (all of them are MD, too). Each one of them have its own CE mark. This group is sold by us as a KIT or procedure pack.

Is posible to change the accesories? for example, sell the kit with one accesory called X, and at the same time with the accesory called X1. But only if the accesory X and X1 are similar in characterics. Is it according art. 12 MDD 93/42 /EEC?


:thanx:
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
Re: Procedure pack - KIT - Each one of them have its own CE Mark

In my opinion if X and X1 are different devices, eg from different manufacturers and/or with different ID / SKU, then you have 2 kit configurations and you need to follow Article 12 separately for each, even though those kits are quite similar.

If it's just a matter of name difference (actually the same physical device with the same intended purpose etc.) I would declare the two configurations and cover any (minor) differences in a single Article 12 file.

Cheers,
Ronen.
 
Last edited:
B

belemsanchez

#3
Re: Procedure pack - KIT - Each one of them have its own CE Mark

Yes, I think it's the best way.

My company wants use several diferent manufactures of the accesories, so I understand that we have to make diferent kits (diferent ID) depending the accesory inside the kit.

Thanks a lot¡
 

pkost

Trusted Information Resource
#4
Re: Procedure pack - KIT - Each one of them have its own CE Mark

from your last post its not clear to me whether device X is the same as X1 in every way except it's site of manufacture

If they are identical then the procedure pack is not different.
 
B

belemsanchez

#5
Re: Procedure pack - KIT - Each one of them have its own CE Mark

Sorry, our KIT (with a ID Y) has an accesory that is a lubricating gel, we use a lubricating X, but my doubt is if we can sell our KIT Y with other lubricating gel X1. Both lubricating has the same intended purpose but are from diferent manufactures.

In this case I'm not sure if we have to make other KIT Y1 or not.

Thanks again
 

xcanals_tecno-med.es

Involved In Discussions
#6
Dear Belem

I noticed that you are loacated in Spain, so as per Royal Decree 1591/2009 you must have a license from the AEMPS (national health authority) to do this activity and made a communication (registration) of this procedure pack according article 22 in the PMPS database (paying 100 Eur) as they include devices class IIa (or IIb or III). If only class I devices the database is RPS (without taxes)
In this communication you must include the certificates CE (for class IIa, ...) and the DoC (for class I devices), so if one device changes also you need to perform a new registration

Xavier Canals
 
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