MDR and Creative Clinical Evidence

[jiligan]

Hello all, This morning I watched a webinar which was about preparing for MDR. In the presentation, the speaker mentioned coming up with creative ideas to use for clinical evidence which would be less costly than clinical trials. She suggested possibly using focus groups, establishing a registry and electronic health records. Could I please get some input on what the most cost saving and effective way to gather clinical evidence would be? and if you know the ballpark price?

 

[Ronen E]

Can’t answer your questions, but mind you that “clinical data” can only be gathered where devices are being clinically used.



The MDR, Article 2 (51):

'clinical evidence' means clinical data and clinical evaluation results pertaining to a device of a sufficient amount and quality to allow a qualified assessment of whether the device is safe and achieves the intended clinical benefit(s), when used as intended by the manufacturer;

The MDR, Article 2 (48):

‘clinical data' means information concerning safety or performance that is generated from the use of a device and is sourced from the following:

— clinical investigation(s) of the device concerned,

— clinical investigation(s) or other studies reported in scientific literature, of a device for which equivalence to the device in question can be demonstrated,

— reports published in peer reviewed scientific literature on other clinical experience of either the device in question or a device for which equivalence to the device in question can be demonstrated,

— clinically relevant information coming from post-market surveillance, in particular the post-market clinical follow-up;

 

[jiligan]