Two different Class II Medical Devices which are Used Together - Spain Requirements

P

putnam1980

#1
Two different class iib devices, both individually CE marked and notified to Spanish notified body. (one is a catheter the other is a surgical laser). No cross-labeling is intended. However, in order to use them together, do any further notifications needs to be made? References would be very helpful. Thanks.
 
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Ronen E

Problem Solver
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Moderator
#2
Re: Two different Class II Medical Devices which are Used Together - Spain Requiremen

Two different class iib devices, both individually CE marked and notified to Spanish notified body. (one is a catheter the other is a surgical laser). No cross-labeling is intended. However, in order to use them together, do any further notifications needs to be made? References would be very helpful. Thanks.
I think not but to make sure you could ask that Spanish notified body.
 
P

putnam1980

#3
Re: Two different Class II Medical Devices which are Used Together - Spain Requiremen

A twist perhaps? The two devices will be used within the context of a clinical trial used to assess a surgical procedure which will, hopefully, support reimbursement.

Still okay with the current registrations of each individual component device?

Thanks.
 

RA Guy

Involved In Discussions
#4
Re: Two different Class II Medical Devices which are Used Together - Spain Requiremen

Are you applying Article 12? Does the use of the two devices in concert make it a system or proceudre pack? If this is the case, you need a declaration of conformity to article 12 (and of course the evidence to back up the declaration).

I have done this in the past with medical systems that can use third party CE marked accessories (plug in sensors, etc.).

I don't recall what I did in terms of notifications as it was several years ago.
 

Ronen E

Problem Solver
Staff member
Moderator
#5
Re: Two different Class II Medical Devices which are Used Together - Spain Requiremen

A twist perhaps? The two devices will be used within the context of a clinical trial used to assess a surgical procedure which will, hopefully, support reimbursement.

Still okay with the current registrations of each individual component device?

Thanks.
The MDD includes provisions for clinical investigations (refer article 15 and annex VIII) and these should be followed when conducting a clinical trial.
 
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