Level of Clinical Evidence - MDR

[ShRam]

Hi Folks,

I need clarification on "Level of Clinical Evidence" which is mentioned in Article 61 (Clinical Evaluation) of Medical Device Regulations. MDR says, "The manufacturer shall specify and justify the level of clinical evidence necessary to demonstrate conformity with the relevant general safety and performance requirements".

Here, what does the level of clinical evidence mean? How to identify the level of clinical evidence?

Hope someone can clarify this.

TIA!

 

[Marcelo]

Hi Folks,

I need clarification on "Level of Clinical Evidence" which is mentioned in Article 61 (Clinical Evaluation) of Medical Device Regulations. MDR says, "The manufacturer shall specify and justify the level of clinical evidence necessary to demonstrate conformity with the relevant general safety and performance requirements".

Here, what does the level of clinical evidence mean? How to identify the level of clinical evidence?

Hope someone can clarify this.

TIA!

The level of evidence mentioned in Article 61 is related to the methods utilized in the appraisal step to to determine the clinical value of data.
You can see an example here: Level of Evidence - Basic Science - Orthobullets

Please note that the Level of evidence is linked to the quality of evidence and strength of recommendation.

I also suggest looking at the 3-part paper named "Grading quality of evidence and strength of recommendations in clinical practice guidelines"

You should also check the GRADE website - GRADE home

And the GRADE handbook: https://www.radioterapiaitalia.it/wp-content/uploads/2017/01/Grade-approach.pdf

 

[Marcelo]

Related to my last comment on level of evidence for the clinical evaluation of medical devices, I put a link to the GRADE website and handbook, but forgot to mentioned that there's a 22-part GRADE Guidelines published in the Journal of Clinical Epidemiology. The name of each paper is in the attached document.

 

[ShRam]

Related to my last comment on level of evidence for the clinical evaluation of medical devices, I put a link to the GRADE website and handbook, but forgot to mentioned that there's a 22-part GRADE Guidelines published in the Journal of Clinical Epidemiology. The name of each paper is in the attached document.

Thank you so much!