CE Mark of a purchased Medical Device with different IFU

c.mitch

Quite Involved in Discussions
#1
Hello,

My company wants to purchase a motor for surgery. It is CE marked in class IIa for a different indication for use than the one we want.
We want to connect our own instruments to this motor and use it for our own indication of use. It is class IIb. We want to mark it CE for pre clinical tests. The main standard to undertake is 60601-1.

We've never had this case before. What we plan to do is:
-redo the risk analysis with our own IFU and instrument,
-produce the risk management proofs with the following cases
1.a sub set of risks are mitigated by the proofs given by the manufacturer of the motor
2.the other risks shall be mitigated with our own proofs

Any comments on this plan ?

Thanks a lot.
 
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Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#2
A quick "Bump". Can anyone help with this one? Please - Help if you can. My Thanks in advance!
 

Ronen E

Problem Solver
Staff member
Moderator
#3
Hello,

My company wants to purchase a motor for surgery. It is CE marked in class IIa for a different indication for use than the one we want.
We want to connect our own instruments to this motor and use it for our own indication of use. It is class IIb. We want to mark it CE for pre clinical tests. The main standard to undertake is 60601-1.

We've never had this case before. What we plan to do is:
-redo the risk analysis with our own IFU and instrument,
-produce the risk management proofs with the following cases
1.a sub set of risks are mitigated by the proofs given by the manufacturer of the motor
2.the other risks shall be mitigated with our own proofs

Any comments on this plan ?

Thanks a lot.
Hi,

I don't see any problem with what you're suggesting (the way it is suggested, which actually says very little); however, there may be additional work to be done outside risk management. Unfortunately I wouldn't be able to comment much further without carefully studying the details, which is not a 5-minute-job :(.

Cheers,
Ronen.
 
M

MIREGMGR

#4
Does the motor manufacturer's CE certificate indicate a limited scope of application for their particular products? Is your application within their CE scope? If they learn that your application is inconsistent with their declared intended use, can they legally sell you motors?
 

c.mitch

Quite Involved in Discussions
#5
Hi all,

We spent a long time thinking about our situation.
I agree with you, Ronen, this is not simple to handle it through a forum where I can't disclose all information about what we're doing.


Does the motor manufacturer's CE certificate indicate a limited scope of application for their particular products? Is your application within their CE scope? If they learn that your application is inconsistent with their declared intended use, can they legally sell you motors?
First question : yes

2nd : yes we fall out of their CE scope. We have to submit a new technical file (see paragraph after article 12 2.c in the EC directive). But we're lucky, it remains in the same class of risk and is used by the same type of users in the same type of environment. So we have all information in their technical file.
We redo our own technical file. We keep design documents, test documents, and change notice, labelling and risk analysis.

3rd : yes, but we loose the CE mark in the transaction. Therefore we have to submit a new tech file with respect to annexes of EC directive.

I haven't spoken about applied parts yet. This is our next big step...

Hope our own experience will help.
I'll give news when we have feedback from our notified body.

Bye.
 

Ronen E

Problem Solver
Staff member
Moderator
#6
Hi all,

We spent a long time thinking about our situation.
I agree with you, Ronen, this is not simple to handle it through a forum where I can't disclose all information about what we're doing.

First question : yes

2nd : yes we fall out of their CE scope. We have to submit a new technical file (see paragraph after article 12 2.c in the EC directive). But we're lucky, it remains in the same class of risk and is used by the same type of users in the same type of environment. So we have all information in their technical file.
We redo our own technical file. We keep design documents, test documents, and change notice, labelling and risk analysis.

3rd : yes, but we loose the CE mark in the transaction. Therefore we have to submit a new tech file with respect to annexes of EC directive.

I haven't spoken about applied parts yet. This is our next big step...

Hope our own experience will help.
I'll give news when we have feedback from our notified body.

Bye.
Hi,

Thanks for the update.

First, if you'd feel more comfortable doing that, please feel free to send me a PM with more details. I don't mind signing a NDA to your benefit, if need be.

Second, I'm not sure article 12 is applicable in your case. You used the term "connect", while article 12 relates to "putting devices together". I would say that if you do non-trivial assembly (i.e. that could not be easily done by the end user), not just pack together, then this would constitute manufacturing rather than "putting together" a system or a procedure pack.

Either way, while not exempting you from conformity assessment, please note that article 11(7) works in your favour.

Last thing, in the OP you referred to "pre-clinical tests". Please note that devices used in the EC for clinical investigations (in humans) are subject to different provisions under the MDD. If "pre-clinical" means animal study then I'm not sure you should be concerned with the MDD at this stage.

Cheers,
Ronen.
 

c.mitch

Quite Involved in Discussions
#7
Hi,

Thanks Ronen for your proposition. However I prefer to limit my involvement in this forum to conversations between gentlemen.

In the meantime, we definitely made-up our minds. Looking at either articles 11(7) or 12, we decided to consider the device as a part of a larger one. With its applied parts and many other things.
In particular, the clinical data collected about that device, even if they're not in the scope of our intended use, are used to do the risk assessment in the scope of our intended use.
We don't have any fast track, we have to submit a full tech file to our NB.

Thanks all.
 

somashekar

Staff member
Super Moderator
#8
Hello,

My company wants to purchase a motor for surgery. It is CE marked in class IIa for a different indication for use than the one we want.
We want to connect our own instruments to this motor and use it for our own indication of use. It is class IIb. We want to mark it CE for pre clinical tests. The main standard to undertake is 60601-1.

We've never had this case before. What we plan to do is:
-redo the risk analysis with our own IFU and instrument,
-produce the risk management proofs with the following cases
1.a sub set of risks are mitigated by the proofs given by the manufacturer of the motor
2.the other risks shall be mitigated with our own proofs

Any comments on this plan ?

Thanks a lot.
You are on the track. The motor is a critical component of your medical device. No motor is ever made with indication for use in medical device application. It is a matter of selection by the user. Is that motor also having a safety mark, as this can help application strongly. Your NB should have no objection on your route to CE
 
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