Coexisting Investigational Use and CE-Mark - Adding a new Indication

[Rocke]

Hello,

If an in vitro diagnostic medical device is CE-marked, but being investigated for a new indication, what would you put on the label (of the devices being used in the performance evaluation)?

1. For investigational use only
2. CE-mark
3. Both

The product would not be commercialized, I am only talking about the labeling of products used to generate clinical data.


Best regards
Camilla

 

[Pads38]

I would label it with the CE mark only.

It is fully identified and marked for it's original purpose.
The fact that it is now being used "off label" should not affect it's current labeling.

 

[Ronen E]

I would label it with the CE mark only.

It is fully identified and marked for it's original purpose.
The fact that it is now being used "off label" should not affect it's current labeling.

I respectfully disagree. Once the legal manufacturer is aware of any off-label use (let alone when that manufacturer provides labeling to support such use) it becomes part of the intended use, whether or not explicitly called out in the labeling.

Showing the CE mark in that case would mean that the device is fully compliant with all applicable regulations under the new (evaluated) indication, which is probably not the case. I would create targeted labeling for the evaluation only, avoid CE marking and follow the IVDD instructions on investigational use only.

Cheers,
Ronen.

 

[Pads38]

Interesting considerations Ronen.

If a manufacturer supplies a (CE marked) device to, say, Dr X for it's official intended purpose. Dr X then decides to try the device for some additional purpose. The manufacturer has no control over this; I would suggest that the CE mark remains valid and correct.

Perhaps, if the manufacturer is then approached by Dr Y, to supply the device for the new purpose - that would be where the 'clinical investigation' requirements would apply.

So the markings would be in accordance with the purpose for which the device was originally supplied.

I think that this may be covered by MDD Article 15 para 8

The provisions of paragraphs 1 and 2 do not apply where the clinical investigations are conducted using devices which are authorized in accordance with Article 11 to bear the CE marking unless the aim of these investigations is to use the devices for a purpose other than that referred to in the relevant conformity assessment procedure.

 

[Ronen E]

I believe that the applicable provisions are the IVDD's "performance evaluation" ones.