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EU MDR Art. 22 - Device + insertion pack - User manual and Labeling

#1
We are working on our gap analysis for the transition from MDD to MDR and are struggling with Art 22. We manufacture a medical device (Class IIa) that requires the purchase of an insertion pack (Class IIb) for every procedure. The insertion pack includes a condom, which qualifies as a "Medical Device" but has its own CE mark. The device + insertion pack have all been validated and verified to work together.

Where we are getting tripped up is whether we are required to add an additional statement to our user manual and labeling for including this condom in the pack. Does anyone have any suggestions?
 

Ronen E

Problem Solver
Staff member
Super Moderator
#2
To get us started:
1. Are you selling your class IIa device and the insertion pack as a procedure pack?
2. Who manufactures the insertion pack?
3. Is the insertion pack CE marked?
4. Is your class IIa device CE marked stand-alone?
 
#3
Thanks Ronen!

1. The class IIa device is a large capital expenditure and the Class IIb insertion pack is sold per procedure.
2. We manufacture the majority of the insertion pack, except for the condom and gel.
3. The insertion pack is CE marked.
4. The Class IIa device is also CE marked as a stand alone device
 

Ronen E

Problem Solver
Staff member
Super Moderator
#4
Thanks Ronen!

1. The class IIa device is a large capital expenditure and the Class IIb insertion pack is sold per procedure.
2. We manufacture the majority of the insertion pack, except for the condom and gel.
3. The insertion pack is CE marked.
4. The Class IIa device is also CE marked as a stand alone device
Thanks, I think I understand a little better now.

To begin with, I now conclude that the class IIa capital expenditure device is quite irrelevant to the Article 22 aspect.

The insertion pack is probably either an accessory (to the class IIa device) or a Procedure Pack.

If you handle it as an accessory (practically, as a stand alone medical device), the condom's status is not that relevant - it's a component in a device, though the fact that it's CE marked should mean that reviewers / auditors shouldn't scrutinise it in great detail unless you somehow modify it in your process or deviate from its manufacturer's intended use (should - doesn't guarantee that they won't).

If you handle it a s a Procedure Pack you have to draw up the statement and otherwise follow through Article 22; however in this case the pack shouldn't be CE marked. The statement doesn't have to be part of the manual. Verification/validation of properly working together (as in Article 22) relates to the procedure pack itself, i.e. the condom, gel and the rest, not to the PP and the class IIa device it serves.
 
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