Medical device should have a clinical benefit?

[TomQA]

Hello, this might sound like a trivial question : but should a medical device have a "clinical benefit" as defined by the MDR?
If yes, where is mentioned in the MDR that it should have ? Because I am asking for instance for Class I devices it might not be trivial to define a "clinical benefit" (and therefore find clinical evidence etc. for clinical evaluation).
Thank you very much!

 

[Hi_Its_Matt]

Hi Tom,
Your question is not as trivial as it may seem. There are actually a host of medical devices that do not provide a traditional (or really any) clinical benefit. The ones I always think of are cosmetic contact lenses and lip/tissue fillers. Both of these products have many adverse event horror stories, and the FDA has issued several warning letters to manufacturers and importers of the contact lenses.
My experience is all in Class 2 and 3 devices, and I have not followed the regulation of these devices closely. So while I can’t claim to be an expert in this area, I did find this article (EU MDR Now Regulates Beauty Devices As Medical Devices) that has some good information.

 

[Ed Panek]

I believe so. Indications for Use is how and where you would use your device. I might be mixing FDA terms with MDR however the clinical reason your device provides better than no treatment or the standard of care in some way is needed. For example, in the USA a cliniican should provide a statement the device is providing clinical benefit for a De Novo submission. They dont want to regulate devices that are not medical

 

[Hi_Its_Matt]

The MDR definition includes:

…modification of the anatomy or of a physiological or pathological process or state

This could include modifications (to e.g. eye color or tissue appearance) that does not provide a clinical benefit.

 

[dgrainger]

MDR - annex I

1. Devices shall achieve the performance intended by their manufacturer and shall be designed and manufactured in such a way that, during normal conditions of use, they are suitable for their intended purpose. They shall be safe and effective and shall not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety, taking into account the generally acknowledged state of the art.


Cosmetic contact lenses and lip/tissue fillers are dealt with under Annex XVI products and the related Common specifications. It is clear that these have no clinical benefit and make it illegal to claim that they have a benefit - See "COMMISSION IMPLEMENTING REGULATION (EU) 2022/2346"