Clinical Evaluation - MEDDEV 2.7/1 rev4 - Literature route

[m8r-lhgra4]

Hi all, I was wondering given that MEDDEV 2.7/1 rev4 requires equivalent (clinical, technical, biological) device to be used in clinical data and some NB even ask for technical data of the equivalent device. Is literature route still possible? It seems like an overkill for existing mature Class I or IIa device to perform clinical investigations (clinical trials).

clinical investigation(s) or other studies reported in the scientific literature, of a similar device for
which equivalence to the device in question can be demonstrated; or
- published and/or unpublished reports on other clinical experience of either the device in
question or a similar device for which equivalence to the device in question can be
demonstrated.

 

[Marcelo]

Yes, the literature route is still possible and is usually used for classes I and IIa devices.

 

[Philip B]

The advice I have received is that clinical investigations should not be necessary for low risk devices providing that there is sufficient evidence from bench testing, risk management outputs, literature searches etc to support the clinical claims you are making for the device and that there are no unacceptable clinical risks outstanding.

If you are claiming equivalence with another device you need to justify this in detail for all clinical, biological and technical characteristics. For higher risk devices (IIb, III) claims of equivalence are more difficult as is justifying not doing a clinical investigation. For all devices a clinical evaluation must be carried out and a clinical evaluation report issued as per the requirements in MEDDEV 2.7.1/4.

Your mature devices presumably have a long safe history of use supported by positive literature returns (and absence of negative returns) which you can also reference in the report.

Hope this helps.